MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-15 for GYRUS ACMI 61224 manufactured by Gyrus Acmi.
[102930762]
Provider used a 24 cm 12/14 fr ureteral access sheath over a guide wire per routine. The sheath was intact when it was inserted in the patient however at the bladder neck the provider encountered difficulty passing the sheath over the wire. The provider removed the sheath and noticed that part of the tip had fragmented. He immediately inspected the entire urethra including the prostatic urethra and bladder neck and noticed 4 small white pieces of plastic. The provider drained the bladder and retrieved all the pieces through the cystoscope sheath. He further inspected these areas with the cystoscope and confirmed that there were no remaining pieces of plastic. The provider reports the sheath has been used on numerous occasion without difficulty. This was reported to be a defective sheath. The second sheath was advanced without difficulty. Thankfully there were no injuries to the patient or staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075914 |
| MDR Report Key | 7344792 |
| Date Received | 2018-03-15 |
| Date of Report | 2018-03-14 |
| Date of Event | 2018-03-13 |
| Date Added to Maude | 2018-03-16 |
| 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 |
| 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 | 0 |
| Brand Name | GYRUS ACMI |
| Generic Name | ACCESSORIES, CATHETER, G-U |
| Product Code | KNY |
| Date Received | 2018-03-15 |
| Model Number | 61224 |
| Catalog Number | 61224 |
| Device Expiration Date | 2018-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-15 |