MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2009-05-05 for ROTO-CAM MARYLAND DISS MONO 5 625126 manufactured by Tontarra Medizintechnik Gmbh.
[1154374]
The customer initially reports, via a copy of their medwatch, that a maryland dissector broke intra-abdominally during a laparoscopic surgery. The surgeon was unable to retrieve a small metal piece approximately the size of a staple. There was no pt injury reported. The loss prevention specialist reported to me that a nissen-fundoplication was being performed on a (b)(6) male pt when the reported issue took place. A pediatric ultrasound of the gallbladder was performed and their was no documentation of visualizing the metal piece. She further stated that the "portion of the device that failed was at the hinge above the grasper. There was no concern about the metal piece in reference to further tests because the size of the piece was congruent with staples that are normally left in the body, therefore they decided there was no further need for intervention. "
Patient Sequence No: 1, Text Type: D, B5
[8143034]
To date the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported information. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680515-2009-00002 |
| MDR Report Key | 1380190 |
| Report Source | 05,08 |
| Date Received | 2009-05-05 |
| Date of Report | 2009-04-16 |
| Date of Event | 2009-03-15 |
| Date Facility Aware | 2009-03-30 |
| Date Mfgr Received | 2009-04-22 |
| Date Added to Maude | 2010-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE, RN, BSM |
| Manufacturer Street | DAIMLERSTRASSE 15 |
| Manufacturer City | WURMLINGEN 78573 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78573 |
| Manufacturer Phone | 461965760 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTO-CAM MARYLAND DISS MONO 5 |
| Generic Name | NA |
| Product Code | HRR |
| Date Received | 2009-05-05 |
| Catalog Number | 625126 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TONTARRA MEDIZINTECHNIK GMBH |
| Manufacturer Address | DAIMLERSTRASSE 15 WURMLINGEN 78573 GM 78573 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-05 |