MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2012-09-04 for INFRAVISION URETRAL KIT 0220180516 manufactured by Stryker Endoscopy San Jose.
[2882164]
It was reported that catheters blink only at the distal end. The procedure was not delayed and was completed successfully. The patient began to bleed as the unit was being inserted into the ureter and was noticed during the first insertion. It was further reported that a new catheter was used and it functioned properly.
Patient Sequence No: 1, Text Type: D, B5
[10180339]
A quantity of two units, same part and lot number, were implicated in this event. Please refer to medwatch report number 2936485-2012-00474 for unit #1. Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2012-00475 |
| MDR Report Key | 2748095 |
| Report Source | 00,04 |
| Date Received | 2012-09-04 |
| Date of Report | 2012-08-09 |
| Date of Event | 2012-08-08 |
| Date Mfgr Received | 2012-08-09 |
| Date Added to Maude | 2012-12-18 |
| 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 | TOM SHAFER |
| Manufacturer Street | 5900 OPTICAL CT. |
| 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 CT. |
| 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 URETRAL KIT |
| Generic Name | URETRAL KIT |
| Product Code | FAT |
| Date Received | 2012-09-04 |
| Catalog Number | 0220180516 |
| Lot Number | PSTR1167-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Address | SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-04 |