MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-09 for PKG, 5MM PEEK MONOPOLAR HANDLE 0250080617 manufactured by Stryker Endoscopy-san Jose.
[107980865]
Additional information will be provided once the investigation has been completed. The device manufacturer date is not known at this time. However, should it become available it will be provided in future reports. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107980866]
It was reported that the insulation had been compromised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2018-00415 |
| MDR Report Key | 7501366 |
| Date Received | 2018-05-09 |
| Date of Report | 2018-08-01 |
| Date of Event | 2018-04-13 |
| Date Mfgr Received | 2018-04-13 |
| Date Added to Maude | 2018-05-09 |
| 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 | 0 |
| Brand Name | PKG, 5MM PEEK MONOPOLAR HANDLE |
| Generic Name | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED |
| Product Code | OCZ |
| Date Received | 2018-05-09 |
| Returned To Mfg | 2018-04-24 |
| Catalog Number | 0250080617 |
| Lot Number | 1241407D |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-05-09 |