MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC CAPTURA HOT BIOPSY FORCEPS; KGE, FORCEPS, BIOPSY, ELECTRIC

Model Number	G31583
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Laceration(s) of Esophagus (2398); Gastrointestinal Hemorrhage (4476)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continued: section g: 510k: k171973.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.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: the information provided indicated that during an endoscopic submucosal dissection, the hot biopsy forcep was used for hemostasis.Use of the device for hemostasis is against the intended use and is most likely the cause for the reported observation.The intended use states, "this device is used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps.Note: do not use this device for any purpose other than stated intended use." 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 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 and this represents an isolated occurrence.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.Additional comments regarding this report: based on the information provided that the forceps were used for hemostasis during an endoscopic submucosal dissection and use of the device for hemostasis is against the intended use, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event or Problem Description
During an endoscopic submucosal dissection of the esophagus [abnormal use], the physician used a cook captura hot biopsy forceps.The lesion was separated by thermal biopsy forceps to stop bleeding, and the front end of the biopsy forceps was suddenly bent and broken, resulting in the rupture of the blood vessel, and the muscle of the esophageal wall where the blood vessel was located penetrated wound.Bleeding control [was required].User immediately replace with a new biopsy forceps and clip the ruptured vessel to stop bleeding with a titanium clip.No other adverse effects were reported.

• Brand Name: CAPTURA HOT BIOPSY FORCEPS
• Common Device Name: KGE, FORCEPS, BIOPSY, ELECTRIC
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 20822194
• Report Number: 1037905-2024-00773
• Device Sequence Number: 15374392
• Product Code: KGE
• UDI-Device Identifier: 00827002315839
• UDI-Public: (01)00827002315839(17)270405(10)W4826044
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G31583
• Device Catalogue Number: HDBF-2.4-230-S
• Device Lot Number: W4826044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE-UNKNOWN MAKE OR MODEL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown