PURSTRING 020242

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-26 for PURSTRING 020242 manufactured by Us Surgical Puerto Rico.

Event Text Entries

[83728560]
Patient Sequence No: 1, Text Type: N, H10


[83728561] According to the reporter, during placing of the purstring on bowel in an open colon resection last (b)(6), the device did not fire correctly and had poor staple formation. They over sewed the staple line to fixed the issue. They hand sutured the purstring to resolve the issue in order to complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


[118113504] Evaluation summary: post market vigilance (pmv) led an evaluation of one device. The visual inspection of the cartridges noted the instrument was fully applied. The instrument was received with pushers fully advanced; the cartridges were seated properly after firing. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer's quality release specifications at the time of manufacture. Should new information become available, the file will be re-opened and the investigation summary amended as appropriate. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2647580-2017-06284
MDR Report Key6823087
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-08-26
Date of Report2017-12-14
Date of Event2017-07-26
Date Mfgr Received2017-11-17
Date Added to Maude2017-08-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSHARON MURPHY
Manufacturer Street60 MIDDLETOWN AVE
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925267
Manufacturer G1US SURGICAL PUERTO RICO
Manufacturer Street201 SABANETAS INDUSTRIAL PARK
Manufacturer CityPONCE PR 007164401
Manufacturer CountryUS
Manufacturer Postal Code007164401
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePURSTRING
Generic NameCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGDJ
Date Received2017-08-26
Returned To Mfg2017-08-09
Model Number020242
Catalog Number020242
Lot NumberP7F1258X
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerUS SURGICAL PUERTO RICO
Manufacturer Address201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-26

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