MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Model Number	G50697
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.We can confirm that the device has been cut at the distal end of the device.The device was returned with the coiled sheath being cut at 11.2 cm from the distal end of the device.The rest of the device, which would be the handle, and rest of the cable where not returned.There is damage on the distal tip of the sheath.One of the forceps forks has come off the cable.The weld indentations are present but are not as deep as the indentations on the other fork.The other forceps fork that is still attached has visible deep weld marks.The forceps cups are stuck closed due to some substance inside the cups; the spike has moved down and the backside of the spike is sticking out near the pivot pin.The forceps cups are still attached at the pivot pin, and nothing is missing from the distal end.Where the user cut the distal end off, the wires looked pinched.During a visual inspection of the forceps cups, the cups were determined to be potentially misaligned.The device will be sent back 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.Investigation conclusion: the product was returned to the approved supplier for evaluation and 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, the physician used a cook captura pro biopsy forceps with spike.After the third or fourth bite, they could not pull the forceps out of the endoscope.They had to cut the forceps to be able to remove the device.The endoscope and device were removed together and the device was cut outside of the patient.The procedure was completed with another of the same forceps.There was no reportable information at this time.The picture provided indicates that the forceps were in the closed position and the forceps arm fork was broken.There was no reportable information at this time.The device was received for evaluation on 25-feb-2019 and it was determined that the forceps cups were 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, the physician used a cook captura pro biopsy forceps with spike.After the third or fourth bite, they could not pull the forceps out of the endoscope.They had to cut the forceps to be able to remove the device.The endoscope and device were removed together and the device was cut outside of the patient.The procedure was completed with another of the same forceps.There was no reportable information at this time.The picture provided indicates that the forceps were in the closed position and the forceps arm fork was broken.There was no reportable information at this time.The device was received for evaluation on 25-feb-2019 and it was determined that the forceps cups were 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
This report is being sent to correct - date of event from (b)(6) 2018 to (b)(6) 2019 and - report date from 22-feb-2019 to 21-feb-2019.Occupation: non-healthcare professional.Investigation evaluation: three (3) photos were provided by the user.From the pictures it appears that one of the fork arms detached from the coil cable, but were attached at the pivot pin.Our laboratory evaluation of the product said to be involved confirmed the report.The device has been cut at the distal end of the device.The device was returned with the coiled sheath being cut at 11.2 cm from the distal end of the device.The rest of the device, which would be the handle, and rest of the cable were not returned.There was damage on the distal tip of the sheath.One of the forceps forks has come off of the coiled cable.The weld indentations were present but are not as deep as the indentations on the other forceps fork.The other forceps fork that was still attached has visible deep weld marks.The forceps cups were stuck closed due to some substance inside the cups; the spike has moved down and the backside of the spike was sticking out near the pivot pin.The forceps cups were still attached at the pivot pin, and nothing was missing from the distal end.Where the user cut the distal end off, the wires looked pinched.During a visual inspection of the forceps cups, the cups were visually misaligned.The device was sent back to the supplier for further evaluation.The supplier provided the following: one device from the reported event was returned inside of a zip type bag with proof of decontamination.It should be noted that the device returned was not in its original state at release and shipment.The device had been cut at the distal end.The forceps were visually evaluated.There was evidence of extreme damage.The tip was damaged and the fork was deformed.The outer coating was damaged.One fork was no longer attached to the coil cable.The loose fork has evidence that it was welded.There was a visible weld spot on the outside and inside of the loose fork.A functional evaluation was not possible; the device was cut prior to the return for evaluation.Since the device was cut prior to being returned for evaluation, the reported defect of "after third or fourth bite they could not pull the forceps out of the endoscope" could not be verified.However, in the forceps current condition, it was reasonable to believe that it would not fit through an endoscope or function as intended.The device history records were reviewed.The device was manufactured in december 2018.There were defects noted in the manufacturing and/or final quality control checklist records for misaligned cups.The relevance of the defects to the current condition of the device can not be stated with certainty.Follow-up information provided by the supplier stated that a weld spot appeared to be present on the coiled cable indicating that the loose fork arm was at one point attached to the coiled cable.Additionally, the supplier was unable to accurately determine proper alignment of the forceps cups due to one of the fork arms no longer being attached to the device.Even though the supplier could not evaluate for cup misalignment based on the condition of the device, during the evaluation at cook the forceps cups were confirmed to be visually misaligned.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 cause of the fork of the forceps tip becoming detached from the coil cable is unknown.The supplier provided the following: the reported issue "forceps could not be pulled from the endoscope"could not be confirmed due to the condition of the device.All devices receive a 100% visual inspection prior to release and shipment.The instructions for use states the following, to assist the user when removing the forceps from the endoscope: "maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site." the instructions for use also states: "slowly withdraw endoscope while endoscopically monitoring foreign body.While withdrawing forceps from endoscope, wipe excess secretions from cable." 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.
Additional Manufacturer Narrative
Occupation: non-healthcare professional investigation evaluation: three (3) photos were provided by the user.From the pictures it appears that one of the fork arms detached from the coil cable, but were attached at the pivot pin.Our laboratory evaluation of the product said to be involved confirmed the report.The device has been cut at the distal end of the device.The device was returned with the coiled sheath being cut at 11.2 cm from the distal end of the device.The rest of the device, which would be the handle, and rest of the cable were not returned.There was damage on the distal tip of the sheath.One of the forceps forks has come off of the coiled cable.The weld indentations were present but are not as deep as the indentations on the other forceps fork.The other forceps fork that was still attached has visible deep weld marks.The forceps cups were stuck closed due to some substance inside the cups; the spike has moved down and the backside of the spike was sticking out near the pivot pin.The forceps cups were still attached at the pivot pin, and nothing was missing from the distal end.Where the user cut the distal end off, the wires looked pinched.During a visual inspection of the forceps cups, the cups were visually misaligned.The device was sent back to the supplier for further evaluation.The supplier provided the following: one device from the reported event was returned inside of a zip type bag with proof of decontamination.It should be noted that the device returned was not in its original state at release and shipment.The device had been cut at the distal end.The forceps were visually evaluated.There was evidence of extreme damage.The tip was damaged and the fork was deformed.The outer coating was damaged.One fork was no longer attached to the coil cable.The loose fork has evidence that it was welded.There was a visible weld spot on the outside and inside of the loose fork.A functional evaluation was not possible; the device was cut prior to the return for evaluation.Since the device was cut prior to being returned for evaluation, the reported defect of "after third or fourth bite they could not pull the forceps out of the endoscope" could not be verified.However, in the forceps current condition, it was reasonable to believe that it would not fit through an endoscope or function as intended.The device history records were reviewed.The device was manufactured in december 2018.There were defects noted in the manufacturing and/or final quality control checklist records for misaligned cups.The relevance of the defects to the current condition of the device can not be stated with certainty.Follow-up information provided by the supplier stated that a weld spot appeared to be present on the coiled cable indicating that the loose fork arm was at one point attached to the coiled cable.Additionally, the supplier was unable to accurately determine proper alignment of the forceps cups due to one of the fork arms no longer being attached to the device.Even though the supplier could not evaluate for cup misalignment based on the condition of the device, during the evaluation at cook the forceps cups were confirmed to be visually misaligned.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 cause of the fork of the forceps tip becoming detached from the coil cable is unknown.The supplier provided the following: the reported issue "forceps could not be pulled from the endoscope"could not be confirmed due to the condition of the device.All devices receive a 100% visual inspection prior to release and shipment.The instructions for use states the following, to assist the user when removing the forceps from the endoscope: "maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site." the instructions for use also states: "slowly withdraw endoscope while endoscopically monitoring foreign body.While withdrawing forceps from endoscope, wipe excess secretions from cable." 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.
Event or Problem Description
During a colonoscopy, the physician used a cook captura pro biopsy forceps with spike.After the third or fourth bite, they could not pull the forceps out of the endoscope.They had to cut the forceps to be able to remove the device.The endoscope and device were removed together and the device was cut outside of the patient.The procedure was completed with another of the same forceps.There was no reportable information at this time.The picture provided indicates that the forceps were in the closed position and the forceps arm fork was broken.There was no reportable information at this time.The device was received for evaluation on 25-feb-2019 and it was determined that the forceps cups were 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.

• Brand Name: CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE
• Common Device Name: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8444266
• Report Number: 1037905-2019-00150
• Device Sequence Number: 2170603
• Product Code: PTS
• UDI-Device Identifier: 00827002506978
• UDI-Public: (01)00827002506978(17)211210(10)W4155567
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2019

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: 12/10/2021
• Device Model Number: G50697
• Device Catalogue Number: BF-2.4SL-230SP-40
• Device Lot Number: W4155567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 03/22/2019; 03/22/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/16/2019; 05/16/2019
• 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 ENDOSCOPE, UNKNOWN MODEL.; OLYMPUS ENDOSCOPE, UNKNOWN MODEL