MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-21 for UNKNOWN_ENDOSCOPY_PRODUCT UNK_END manufactured by Stryker Endoscopy-san Jose.
[117999154]
Mfg date: the device manufacture date is not known. The reported device was not received for investigation; therefore the reported failure cannot be confirmed. The complaint will be closed without a detailed investigation. In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results. Probable root cause for the reported failure involving this device could not be determined due to insufficient information. The reported failure mode will be monitored for future reoccurrence
Patient Sequence No: 1, Text Type: N, H10
[117999155]
It was reported that the device broke while in use inside of the patient. It was also reported that the broken pieces were retrieved and the case was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2018-00588 |
| MDR Report Key | 7802968 |
| Date Received | 2018-08-21 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-07-24 |
| Date Mfgr Received | 2018-07-24 |
| Date Added to Maude | 2018-08-21 |
| 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 | UNKNOWN_ENDOSCOPY_PRODUCT |
| Generic Name | UNKNOWN |
| Product Code | GCP |
| Date Received | 2018-08-21 |
| Catalog Number | UNK_END |
| 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 | 2018-08-21 |