MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-21 for STRYKERT INFRAVISION URETERAL KIT manufactured by Stryker Endoscopy.
[70745609]
Lighted ureteral stents were not working at the beginning of the procedure then suddenly started working. Route: urethral. Dates of use: (b)(6) 2017. Diagnosis or reason for use: diverticulitis. Is the product over-the-counter: no. Event abated after use stopped or dose reduced: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068582 |
| MDR Report Key | 6427255 |
| Date Received | 2017-03-21 |
| Date of Report | 2017-03-21 |
| Date of Event | 2017-01-26 |
| Date Added to Maude | 2017-03-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRYKERT INFRAVISION URETERAL KIT |
| Generic Name | LIGHT, CATHETER, FIBERPOPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2017-03-21 |
| Lot Number | 1694987 |
| Device Expiration Date | 2018-09-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-21 |