MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-27 for UNKNOWN_ENDOSCOPY_PRODUCT UNK_END manufactured by Stryker Endoscopy-san Jose.
[91087871]
The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[91087872]
It was reported that the device was continuously activating.
Patient Sequence No: 1, Text Type: D, B5
[114853999]
Alleged failure: the customer reported that the wand was firing before any button was pressed. The failure alleged in the complaint record was not confirmed/duplicated during the product investigation. Based on the functional inspection, the probe operated normally upon receipt the customer alleged claim of (wand was firing before any button was pressed) unable to duplicate during testing. The probable root cause/s could be a button stuck on firing position, button inadvertently pressed, probe shorted or defective probe output, defective pcb. A footswitch also can used to activate the rf probe, therefore, use of the footswitch can also be considered a possible root cause. The product was returned for investigation and the reported failure mode was confirmed. The reported failure mode will be monitored for future reoccurrence. Gtin: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[114854000]
It was reported that the device was continuously activating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2017-01016 |
| MDR Report Key | 6983905 |
| Date Received | 2017-10-27 |
| Date of Report | 2018-05-04 |
| Date of Event | 2017-09-29 |
| Date Mfgr Received | 2017-09-29 |
| Device Manufacturer Date | 2017-07-13 |
| Date Added to Maude | 2017-10-27 |
| 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. VALERIE ESTRADA |
| 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 | GEN |
| Date Received | 2017-10-27 |
| Returned To Mfg | 2018-01-03 |
| Catalog Number | UNK_END |
| Lot Number | 17194AE2 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-10-27 |