MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-16 for CAPTURA SERRATED LARGE FORCEP-SPIKE DBF-2.4SL-230SP-40-S manufactured by Cook Endoscopy.
[114556995]
Suspect medical device: common name - forceps, biopsy, non-electric product code- pts. (b)(4). 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 conclusion: 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. The instructions for use state the following in regards to product inspection: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable. Open and close the cups to verify smooth handle operation and appropriate cup action. Become familiar with the amount of handle movement required to operate the cups. If any irregularities are noted, do not use. Note: exercising the handle while the forcep is coiled may result in damage to the performance characteristics of the forceps. " the instructions for use state: "using slight pressure on handle, close forceps around tissue or object. Note: it is not necessary to apply excessive pressure to cleanly excise tissue. " prior to distribution, all captura serrated large forcep- spike 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
[114556996]
During an endoscopic procedure, the physician used a cook captura serrated large forcep-spike. Per the customer, "it was ripping more tissue on the outside of the bite. " a section of the device did not remain inside the patient? S body. It is unknown if the patient required any additional procedures due to this occurrence. It is unknown if the patient experienced any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2018-00317 |
| MDR Report Key | 7691108 |
| Date Received | 2018-07-16 |
| Date of Report | 2018-06-21 |
| Date Mfgr Received | 2018-07-18 |
| Date Added to Maude | 2018-07-16 |
| 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 |
| Manufacturer G1 | COOK ENDOSCOPY |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27105 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPTURA SERRATED LARGE FORCEP-SPIKE |
| Product Code | KGE |
| Date Received | 2018-07-16 |
| Catalog Number | DBF-2.4SL-230SP-40-S |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-07-16 |