MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA PRO BIOPSY FORCEPS WITH SPIKE; KGE, FORCEPS, BIOPSY, ELECTRIC

Model Number	G56999
Medical Device Problem Codes	Mechanical Problem (1384); Dull, Blunt (2407); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 will be provided.
Event or Problem Description
During multiple endoscopic biopsies, the physician used a total of 22 cook captura pro¿ biopsy forceps with spike.The physician noticed that the forceps are not biting the tissue cleanly.The torn tissue left behind is described as "zipper-like".It required extra force to bite the tissue.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.
Event or Problem Description
During multiple endoscopic biopsies, the physician used a total of 22 cook captura pro¿ biopsy forceps with spike.The physician noticed that the forceps are not biting the tissue cleanly.The torn tissue left behind is described as "zipper-like".It required extra force to bite the tissue.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.
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved did not confirm the report.18 sealed devices returned with no sign of damage to device or packaging.The 18 sealed devices will be sent back to the supplier for a full 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 supplier provided the following: functional evaluation: all 18 devices passed all of the fqc requirements.Bite test were performed successfully for all 18 devices, see photographs.The device history records for packaging work order (pt) w4296647 were reviewed.(pt) w4296647 consisted of one pt manufactured december 2019.The manufacturing records and/or final quality control (fqc) checklist did include relevant defects.Pt w4296647 had 10 misaligned cups.Investigation conclusion: the supplier provided the following: the complaint was not confirmed.Each of the 18 sealed devices were evaluated per the requirements of the fqc checklist used at final inspection.All 18 devices passed.In addition, each of 18 returned devices was evaluated by taking biopsy of simulated tissue without issue.Prior to distribution, all captura pro 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.

• Brand Name: CAPTURA PRO BIOPSY FORCEPS WITH SPIKE
• Common Device Name: KGE, FORCEPS, BIOPSY, ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10329862
• Report Number: 1037905-2020-00293
• Device Sequence Number: 10996956
• Product Code: KGE
• UDI-Device Identifier: 00827002569997
• UDI-Public: (01)00827002569997(17)221210(10)W4296647
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2022
• Device Model Number: G56999
• Device Catalogue Number: BF-2.8SJ-230SP-40
• Device Lot Number: W4296647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE, UNKNOWN MAKE OR MODEL