MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-24 for CUP BIOPSY FORCEPS G15054 220130 manufactured by Cook Inc.
[184139584]
Common name: endoscopic grasping/cutting instrument, non-powered. Procode: ocz. Initial reporter: v2m 1s2. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[184139585]
It was reported, during a ureteroscopy with biopsy in the ureter/collecting system that two cup biopsy forceps were used. Both devices broke in half at the cup portion. The broken piece from one of the devices was able to be retrieved, but the broken piece from the other device was not able to be retrieved and was left in the patient. This report will be for the device where they were unable to retrieve the broken piece. Reference patient identifier (b)(6) for the device where they were able to retrieve the broken piece. No additional patient consequences were reported. Additional information has been requested regarding the patient and the event. At the time of this report, no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00442 |
| MDR Report Key | 9746186 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-06-04 |
| Date Added to Maude | 2020-02-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUP BIOPSY FORCEPS |
| Product Code | OCZ |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-03-05 |
| Model Number | G15054 |
| Catalog Number | 220130 |
| Lot Number | 9785614 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |