MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-28 for IRIS URETERAL KIT 0220180518 manufactured by Stryker Endoscopy-san Jose.
[118537763]
The product was not returned for investigation therefore the reported failure mode was not confirmed. The reported failure mode will be monitored for future reoccurrence. Alleged failure: section of catheter not illuminating. Probable root cause: light fiber broken, connected to console incorrectly, non-compatible scope equipment configuration used, incorrect laser source/scope combination used, fiber damage during unpacking from pouch, damage during shipping/ handling. The device manufacture date is not known.
Patient Sequence No: 1, Text Type: N, H10
[118537764]
It was reported that the stent did not fully light up. The procedure was completed successfully and no adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2018-00592 |
| MDR Report Key | 7823521 |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-08-28 |
| 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. CHESTER REBUGIO |
| 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 | IRIS URETERAL KIT |
| Generic Name | LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2018-08-28 |
| Catalog Number | 0220180518 |
| Lot Number | 2250826 |
| 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 | 2018-08-28 |