MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for UROPASS URETERAL ACCESS SHEATH 61054BX manufactured by Gyrus Acmi, Inc..
[174908852]
Male patient scheduled for a cystoscopy, ureteroscopy, stent exchange and laser lithotripsy. During the ureteroscopy procedure, a piece broke off the access sheath. The item was being utilized appropriately by the attending surgeon. The procedure continued on to complete the stent exchange and the laser lithotripsy. Efforts were made by the surgeons to retrieve the broken pieces of the access sheath. Additional time was used to perform a more thorough urteroscopy and cystoscopy to confirm that pieces of the access sheath have been removed. Per the attending surgeon, the patient will be scheduled for a ct scan and follow-up. During the cystoscopy the access sheath was inserted without resistance however upon removal it was noted that the distal tip had broken off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9586271 |
| MDR Report Key | 9586271 |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-03 |
| Report Date | 2019-12-20 |
| Date Reported to FDA | 2019-12-20 |
| Date Reported to Mfgr | 2020-01-14 |
| Date Added to Maude | 2020-01-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | UROPASS URETERAL ACCESS SHEATH |
| Generic Name | ACCESSORIES, CATHETER, G-U |
| Product Code | KNY |
| Date Received | 2020-01-14 |
| Model Number | 61054BX |
| Lot Number | 09M1700013 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 136 TURNPIKE RD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |