MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-05 for INFRAVISION UNIVERSAL URETERAL KIT 0220180517 manufactured by Stryker Endoscopy-san Jose.
[16630345]
It was reported that the device does not blink all the way and only the end part of the device blinks. Procedure was completed successfully with a half and hour delay.
Patient Sequence No: 1, Text Type: D, B5
[16694645]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[25282769]
The product was returned and the failure mode was not confirmed. Visual inspection: the microscope revealed no physical damage to the fiber or the catheter. Only blood was present on both the fiber and the catheter. Functional inspection: unable to test the device due to contamination. The probable root causes for the reported failure involving this device could be due to improper connection of the fiber to the port; infravision ir illuminator failure, or; possible broken fiber. The product was returned for investigation and the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
[25282770]
It was reported that the device does not blink all the way and only the end part of the device blinks. Procedure was completed successfully with a half and hour delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2015-00006 |
| MDR Report Key | 4382779 |
| Report Source | 05 |
| Date Received | 2015-01-05 |
| Date of Report | 2014-12-10 |
| Date of Event | 2014-12-09 |
| Date Mfgr Received | 2014-12-10 |
| Date Added to Maude | 2015-01-21 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. THOMAS SHAFER |
| 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 | 3 |
| Brand Name | INFRAVISION UNIVERSAL URETERAL KIT |
| Generic Name | LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2015-01-05 |
| Returned To Mfg | 2015-01-06 |
| Catalog Number | 0220180517 |
| Lot Number | PSTR 1473-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-01-05 |