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 2018-03-13 for CAPTURA HOT BIOPSY FORCEPS HDBF-2.4-230-S manufactured by Cook Endoscopy.
[102724763]
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation. The report could not be confirmed. A review of the device history record could not be conducted because the lot number was not provided. Investigation evaluation: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation. A definitive cause for the reported observation could not be determined. Prior to distribution, all captura hot biopsy forceps are subjected to a visual inspection and functional test to ensure proper workability. Corrective action: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. Corrective action is not warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Patient Sequence No: 1, Text Type: N, H10
[102724764]
During a biopsy procedure, the physician used a cook captura hot biopsy forceps. The customer reports having trouble with hot biopsy forceps. This "trouble" was reported to be a "similar problem to the problem they were having with the cold biopsy forceps. Apparently the physician has been having issues as well at (b)(6) private hospital. " a search through previous complaints from this facility for cold forceps found that the majority of the complaints were for "unable or difficult to close the forceps cups" (see mdrs 1037905-2017-00194, 1037905-2017-00195, 1037905-2017-00343, and 1037905-2017-00550).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2018-00095 |
| MDR Report Key | 7334834 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-29 |
| Date Mfgr Received | 2018-03-11 |
| Date Added to Maude | 2018-03-13 |
| 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 | MS. SCOTTIE FARIOLE |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURA HOT BIOPSY FORCEPS |
| Generic Name | KGE, FORCEPS, BIOPSY, ELECTRIC |
| Product Code | KGE |
| Date Received | 2018-03-13 |
| Catalog Number | HDBF-2.4-230-S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK ENDOSCOPY |
| Manufacturer Address | 4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-13 |