MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2010-06-02 for 5MM, 33CM HOOK SCISSORS 0250080260 manufactured by Stryker Endoscopy San Jose.
[1411103]
It was reported that the unit needs to be sharpened.
Patient Sequence No: 1, Text Type: D, B5
[8617598]
Additional info will be provided once the investigation is completed. A similar product from lot # 842267 was also implicated in this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2010-00458 |
| MDR Report Key | 1732199 |
| Report Source | 00,04 |
| Date Received | 2010-06-02 |
| Date of Report | 2010-05-25 |
| Date of Event | 2010-05-25 |
| Date Mfgr Received | 2010-05-25 |
| Date Added to Maude | 2010-09-21 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | SUNNY OFFORJEBE |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5MM, 33CM HOOK SCISSORS |
| Generic Name | SCISSORS |
| Product Code | HRR |
| Date Received | 2010-06-02 |
| Catalog Number | 0250080260 |
| Lot Number | 842263 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Address | SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-02 |