MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-11 for UROPASS URETERAL ACCESS 61224 manufactured by Gyrus / Acmi.
[80071570]
As access sheath used during a cystoscopy procedure was found to be broken after use. The tip of access sheath (a white plastic) was noted to be broken in half. As surgeon was placing pieces back together, plastic was deteriorating in his hand. All pieces appeared to be present. Surgeon stated that he completely washed out bladder after incident. Diagnosis or reason for use: cystoscopy, right ureteral stone. "event abated after use stopped or dose reduced: yes. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070955 |
| MDR Report Key | 6710524 |
| Date Received | 2017-07-11 |
| Date of Report | 2017-06-30 |
| Date of Event | 2016-11-01 |
| Date Added to Maude | 2017-07-13 |
| 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 | UROPASS URETERAL ACCESS |
| Generic Name | 12/N FR X 24 CM |
| Product Code | KNY |
| Date Received | 2017-07-11 |
| Catalog Number | 61224 |
| Lot Number | 09HL20009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS / ACMI |
| Manufacturer Address | 136 TURNPIKE RD SOUTHBOROUGH MA 017722104 US 017722104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-11 |