MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-28 for CUP BIOPSY FORCEPS 220130 manufactured by Cook Inc.
[128740986]
The field for section could not be populated due to a technical limitation. Section common name: endoscopic grasping/cutting instrument, non-powered section product code: ocz. This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[128740987]
It was reported that during the biopsy in flexible ureteroscopy procedure, the sheath (outer layer) of the forceps separated completely from the metallic part (coil) of the sheath. This occurred inside the scope and outside of the patient. It was further noted that the small scope had scraped the sheath off the coil assembly. There were no adverse effects to the patient reported due to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03569 |
| MDR Report Key | 8112898 |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-28 |
| Date of Event | 2016-02-25 |
| Date Mfgr Received | 2018-11-26 |
| Date Added to Maude | 2018-11-28 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| 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 | 0 |
| Brand Name | CUP BIOPSY FORCEPS |
| Product Code | OCZ |
| Date Received | 2018-11-28 |
| Returned To Mfg | 2016-03-15 |
| Model Number | NA |
| Catalog Number | 220130 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-11-28 |