MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-10-01 for CAPTURA HOT BIOPSY FORCEPS HDBF-2.4-230-S manufactured by Cook Endoscopy.
[124969923]
Occupation: non-healthcare professional. 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. A visual inspection of the photo provided by the user was performed and we can confirm that a small piece of sheath is frayed. From the photo provided from the user, it does not look as if any coils on the device are exposed. Without substantial evidence to contradict the complaint, it is considered confirmed based solely on statements describing the event. The possible lot numbers of the product said to be involved were used to review the device history records. 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. Prior to distribution, all hot captura biopsy forceps are subjected to a visual inspection and functional test to ensure proper workability. A review of the device history record for the possible lot numbers confirmed that the lots 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
[124969924]
During a colonoscopy procedure, the physician used a cook captura hot biopsy forceps. Per the customer: "i just wanted to report that we had an adverse event today with one of our hot biopsy forceps. A small bit of metal was protruding from the side of the forceps. " per the cook quality engineer, the photograph provided appears to be a pebax tag [sheath was frayed]. It is unknown from the photographs if a section of the inner cables is exposed. Per the completed complaint form from customer obtained on 21-sep-2018, "during use, metal shard observed and forcep removed from scope. " clarification was received from the customer on 21-sep-2018: "the term 'adverse event' was just the wording i used to label the complaint. " 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 | 1037905-2018-00464 |
| MDR Report Key | 7923665 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-10-01 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-09-06 |
| Date Added to Maude | 2018-10-01 |
| 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 | 3 |
| Brand Name | CAPTURA HOT BIOPSY FORCEPS |
| Generic Name | KGE, FORCEPS, BIOPSY, ELECTRIC |
| Product Code | KGE |
| Date Received | 2018-10-01 |
| Catalog Number | HDBF-2.4-230-S |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-01 |