MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-08 for PKG, 5MM PEEK MONOPOLAR HANDLE 0250080617 manufactured by Stryker Endoscopy-san Jose.
[107720030]
The product was returned for investigation and the reported failure mode was confirmed. The failure mode will be monitored for future reoccurrence. Alleged failure: micro holes on shaft insulation. Confirmed failure: micro holes on shaft insulation bent shaft. Probable root cause: poor autoclave reliability, incorrect sterilization/reprocessing procedure, handling procedures, contact forces, product used beyond defined useful life. The device manufacture date is not known. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107720031]
It was reported that the insulation had been compromised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2018-00407 |
| MDR Report Key | 7495123 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-08 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-04-12 |
| Date Mfgr Received | 2018-04-12 |
| Date Added to Maude | 2018-05-08 |
| 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 | 3 |
| Manufacturer Contact | MR. ROOMI BANERJEE DUA |
| 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 | 3 |
| Brand Name | PKG, 5MM PEEK MONOPOLAR HANDLE |
| Generic Name | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED |
| Product Code | OCZ |
| Date Received | 2018-05-08 |
| Returned To Mfg | 2018-04-13 |
| Catalog Number | 0250080617 |
| Lot Number | ?1343947H? |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-08 |