MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-01 for ENDOSCOPY DISPOSABLE SUCTION IRRIGATOR 250-070-400 manufactured by Stryker Endoscopy.
[16960]
Md was using the disposable suction irrigator. During the procedure he was complaining about the handpiece getting hot. Rptr noticed when he got shocked that there was accumulation of tissue on the end of the electrode that could have caused the electricity to gap to the outer sheath and shock his hand that was holding, steadying the outer sheath. No injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005783 |
| MDR Report Key | 21607 |
| Date Received | 1995-05-01 |
| Date of Report | 1995-04-13 |
| Date of Event | 1995-04-12 |
| Date Added to Maude | 1995-05-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSCOPY DISPOSABLE SUCTION IRRIGATOR |
| Generic Name | DISPOSABLE SUCTION IRRIGATOR |
| Product Code | FHF |
| Date Received | 1995-05-01 |
| Catalog Number | 250-070-400 |
| Lot Number | 95036202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21649 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | SAN JOSE CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-05-01 |