MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-01 for PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5) 0220180517 manufactured by Stryker Endoscopy-san Jose.
[93643145]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93643146]
It was reported that fibers were not lighting up when inserted into the catheter. The procedure was completed successfully without any adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2017-01171 |
| MDR Report Key | 7074927 |
| Date Received | 2017-12-01 |
| Date of Report | 2018-03-15 |
| Date of Event | 2017-11-07 |
| Date Mfgr Received | 2017-11-07 |
| Date Added to Maude | 2017-12-01 |
| 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. ROOMI BANERJEE DUA |
| 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 | PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5) |
| Generic Name | LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2017-12-01 |
| Returned To Mfg | 2017-11-13 |
| Catalog Number | 0220180517 |
| Lot Number | 1596543 |
| 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 | 2017-12-01 |