MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA HOT SERRATED FORCEPS W/O SPIKE; KGE, FORCEPS, BIOPSY, ELECTRIC

Model Number	G56135
Medical Device Problem Codes	Failure to Align (2522); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: erbe electrosurgical generator.Investigation evaluation: during the evaluation, the handle was manipulated and the forceps cups would open and close with some resistance felt in the handle.As the handle was manipulated a few more times the cups remained closed when trying to open the forceps cups, but started folding to one side.When the handle was resting in the closed position, the cups straightened back out, however the forceps housing maintained a slight bend.During a visual inspection the cups appeared to be potentially misaligned and there was also a gap in between the teeth where they should come together.Due to the potential misalignment of the cups and a slight bend of the cups inside the fork housing, the forceps were not function tested in the endoscope.The device will be sent back to the supplier for a full evaluation.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.
Event or Problem Description
During a colonoscopy procedure, the physician used a cook captura hot serrated forceps without spike.The device was used to take a biopsy.Then, the physician snared a polyp and tried to use the biopsy forcep to cauterize the bleeding and when the physician put the biopsy forcep back in, the jaws were "just flopping around".The handle was not working.It seems as though the wire was broken on the device.A new [device of the same type] was opened and used to complete the procedure.The device was evaluated and also found to be potentially misaligned.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 a colonoscopy procedure, the physician used a cook captura hot serrated forceps without spike.The device was used to take a biopsy.Then, the physician snared a polyp and tried to use the biopsy forcep to cauterize the bleeding and when the physician put the biopsy forcep back in, the jaws were "just flopping around".The handle was not working.It seems as though the wire was broken on the device.A new [device of the same type] was opened and used to complete the procedure.The device was evaluated and also found to be potentially misaligned.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
Erbe electrosurgical generator.Investigation evaluation: during the evaluation, the handle was manipulated and the cups would open and close with some resistance felt in the handle.As the handle was manipulated a few more times, the cups remained closed when trying to open the forcep cups, but started folding to one side.When the handle was resting in the closed position, the cups would straighten back out, however the forcep housing would maintain a slight bend.During a visual inspection, the cups appear to be potentially misaligned and there is also a gap in between the teeth where they should come together.Due to the potential misalignment of the cups and a slight bend of the cups inside the fork housing, the forcep was not function tested in the endoscope.The device will be sent back to the supplier for a full evaluation.The supplier provided the following: the device was visually evaluated.No defects to the handle or catheter were noted.The cups at the distal tip were visually skewed on the device.The device was functionally evaluated.During testing, with the device held in straight, u­ shaped, and three (3), eight (8) inch loop coiled positions, respectively, it was confirmed that the device did not operate properly when the handle was manipulated.The device opened and closed but with resistance while in straight and u-shaped positions.Prior to the assembly completely opening, the assembly exhibited a "pop".While in the closed position, the assembly exhibited cup misalignment.It was also observed that the pivot pin was loose during actuation of the assembly.The device was evaluated for potentially misaligned cups.Under magnification, the visible material thickness for the device was measured.The reported event for potential misaligned cups was confirmed.The device was disassembled to evaluate the solder connection.The solder connection was intact.The assignable cause for the cup misalignment and difficulty with the cups opening and closing (flopping around) was determined to be a loose pivot pin.The device history records were reviewed.The manufacturing records and/or final quality control checklist indicated relevant defects.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 supplier provided the following: the reported issue from the user "jaws flopping around" was confirmed.The reported issue from the customer "misaligned cups" was confirmed.The assignable cause was determined to be a loose pivot pin due to an assembly error.The operators involved will be advised of the complaint.Prior to distribution, all 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.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 HOT SERRATED FORCEPS W/O SPIKE
• Common Device Name: KGE, FORCEPS, BIOPSY, ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8640969
• Report Number: 1037905-2019-00280
• Device Sequence Number: 2298809
• Product Code: KGE
• UDI-Device Identifier: 00827002561359
• UDI-Public: (01)00827002561359(17)211217(10)W4157767
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K923470
• 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): 04/29/2019

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: 12/17/2021
• Device Model Number: G56135
• Device Catalogue Number: HDBF-2.4SN-230-S
• Device Lot Number: W4157767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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: OLYMPUS 190 ENDOSCOPE.
• Patient Weight: 111