MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for GASTROSCOPE manufactured by Stryker Endoscopy.
[173502275]
Gastroscope was being used in a procedure and a picture couldn't be used due to it "flipping". A stryker rep was called to assist. An attempt was made to replace the data cord, but there was no change. The tower was replaced, but there was no change. Brought in a monitor tower to sync picture, but there was no change. A different scope was exchanged and that solved the problem. The defective scope was removed from service by the stryker rep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9544227 |
| MDR Report Key | 9544227 |
| Date Received | 2020-01-03 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-10-03 |
| Report Date | 2019-10-03 |
| Date Reported to FDA | 2019-10-03 |
| Date Reported to Mfgr | 2020-01-03 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GASTROSCOPE |
| Generic Name | TRAY, SURGICAL, INSTRUMENT |
| Product Code | FSM |
| Date Received | 2020-01-03 |
| Returned To Mfg | 2019-10-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |