MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for PKG, METZENBAUM SCISSORS, CURVED LONG 0250080265 manufactured by Stryker Endoscopy-san Jose.
[116706972]
The product was not returned for investigation therefore the reported failure mode was not confirmed. The reported failure mode will be monitored for future reoccurrence. Alleged failure: broken tip. Probable root cause: poor autoclave reliability, shear pin failure in handle, use error. The device manufacture date is not known.
Patient Sequence No: 1, Text Type: N, H10
[116706973]
It was reported that the tip broke during a procedure. The tip was retrieved successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2018-00574 |
| MDR Report Key | 7760111 |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-06-15 |
| Date Mfgr Received | 2018-07-10 |
| Date Added to Maude | 2018-08-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANDREA ZENERE |
| Manufacturer Street | 5900 OPTICAL COURT |
| 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 COURT |
| 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 | 0 |
| Brand Name | PKG, METZENBAUM SCISSORS, CURVED LONG |
| Generic Name | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED |
| Product Code | OCZ |
| Date Received | 2018-08-07 |
| Catalog Number | 0250080265 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-07 |