MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-07-17 for CAPTURA HOT BIOPSY FORCEPS HDBF-2.4-230-S manufactured by Cook Endoscopy.
[114279434]
Continued from concomitant products: erbe 200d apc2 jet2 electrosurgical generator stack; active cord, unknown make or model. Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described. During the evaluation of the returned device, there were no bends or kinks observed. The continuity from the electrical pin to the forceps cups head was tested with an ohm meter and passed. A functional test was performed. The active cord connected easily and remained securely connected. The device was connected to a valley lab generator and power was applied. The forceps cups were able to burn the simulated tissue as expected. The continuity from the electrical pin to the forceps cups was not intermittent. The device will be sent to the supplier for further evaluation. 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. The product was returned to the approved supplier for evaluation and the investigation is on-going. Once additional information has been received a follow-up emdr report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[114279435]
During an endoscopic submucosal dissection (esd), the physician used a cook captura hot biopsy forceps for hemostasis [abnormal use]. The forceps were connected with the electrosurgical generator, but the current source was on and off which is not stable [inconsistent current]. The user could not use the device properly which resulted in excessive burning of the wound and perforation. The user used several of another manufacturer's hemostasis clips to stop the bleeding. Further information received 13-july-2018: the user followed standard endoscopic mucosal dissection (esd). They used erbe electrosurgical equipment to cut the patient? S early esophageal cancer (area 3-4 mm in size), where there was a slight hemorrhage. The user then used the closed forceps cups to stop the bleeding. No biopsies were performed. Intermittent power from the forceps was noticed. Per the customer, they could not be sure of or control the interval of stepping on the electrosurgical generator pedal to produce current, because the current was intermittent. This caused excessive burning and perforation. The bleeding [noted initially] was stopped with another manufacturer? S hemostasis clips. The power settings on the electrosurgical generator were not reported to be changed to compensate for the malfunction, and other manufacturer? S devices were reported to work with the electrosurgical equipment involved. 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 experienced a perforation. [although intervention for the perforation was not alleged, hospitalization or intervention is often pursued in the clinical setting. Therefore, this event is being reported as an adverse event since the malfunction likely did not cause or contribute to the perforation. ]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2018-00320 |
| MDR Report Key | 7696072 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-07-17 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-07-17 |
| Device Manufacturer Date | 2018-02-14 |
| Date Added to Maude | 2018-07-17 |
| 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 | 2018-07-17 |
| Returned To Mfg | 2018-07-12 |
| Catalog Number | HDBF-2.4-230-S |
| Lot Number | W4033048 |
| 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 | 1. Other | 2018-07-17 |