MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-06-22 for CAPTURA HOT BIOPSY FORCEPS HDBF-2.4-230-S manufactured by Cook Endoscopy.
[112571863]
Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation. In the photo provided by the user, we confirmed that the sheath does not cover the entire length of the coiled catheter. There were three (3) coils of the coiled catheter showing in the photo provided, that were not covered by the outer sheath. It is unknown when this might have occurred. The exposed coils likely contributed to the users report of "forceps are loose from catheter. " the device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. 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 precaution the user, "endoscope must remain as straight as possible when inserting or withdrawing forceps. Forceps cups must remain closed during introduction into, advancement through, and removal from endoscope. If cups are open, damage to forceps and endoscope may occur. Exercising handle while forceps is coiled may result in damage to forceps. " prior to distribution, all captura hot biopsy forceps are subjected to a visual inspection and functional test to ensure proper workability. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. 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
[112571864]
During an endoscopic procedure, the physician used a cook captura hot biopsy forceps. The user completed hemostasis and tried to retract the device from biopsy channel of endoscope, but met resistance. The user withdrew the endoscope along with the forceps in it from patient, and pulled the device from the endoscope biopsy channel afterward [after the endoscope was outside of the patient]. The user found that the forceps are loose from catheter. The photo provided shows the inner cable of the hot forceps exposed. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2018-00271 |
| MDR Report Key | 7629601 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-06-22 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2018-06-26 |
| Device Manufacturer Date | 2018-02-13 |
| Date Added to Maude | 2018-06-22 |
| 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 |
| Reporter Occupation | OTHER CAREGIVERS |
| 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 | 3 |
| Brand Name | CAPTURA HOT BIOPSY FORCEPS |
| Generic Name | KGE, FORCEPS, BIOPSY, ELECTRIC |
| Product Code | KGE |
| Date Received | 2018-06-22 |
| Returned To Mfg | 2018-06-26 |
| Catalog Number | HDBF-2.4-230-S |
| Lot Number | W4033061 |
| 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 ENDOSCOPY |
| Manufacturer Address | 4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-22 |