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

Model Number G56074

Device Problems Device Damaged by Another Device (2915); Difficult to Open or Close (2921); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use product inspection: "beginning at handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Note: exercising the handle while the forceps is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura biopsy forceps with spike are subjected to a visual inspection and functional testing to ensure device integrity.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 Description

During an esophagogastroduodenoscopy (egd), the physician selected a cook captura biopsy forceps with spike.After opening the forceps, it was not possible to close the cups.The hinges were not aligned with the shaft of the forceps, but were sticking out.The forceps could not be pulled back into the working channel of the endoscope without damaging the endoscope.The complete endoscope plus the forceps were taken out carefully.The outside distal portion of the forceps was cut off to take everything out of the endoscope 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.

Manufacturer Narrative

Information regarding ec method code desc - incomplete device returned (4116).Investigation evaluation: images with the returned device.The images were taken when the device was in the patient.One image, the forceps are open and the proximal end of the spike is sticking out the side of the device.The second image is of the device closed and the proximal end of the spike is sticking out the side of the device.The pictures confirm the customer¿s difficulty removing the device from the endoscope.The device was returned with the distal end cut off, and the distal end was not included with the returned device.The device handle was manipulated and one of the wires inside the device sticks out when opening.There were no other anomalies detected.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 device was returned to the supplier.The supplier provided the following.Visual evaluation: no defects were noted to the assembly handle.The device was returned with the outer sheath completely severed approximately 228.6 cm distal from the nose cap.The cup's assembly could not be evaluated due to the condition of the device.Functional evaluation: the handle was manipulated and the control wire extended and retracted as designed.The cup's assembly could not be evaluated due to the condition of the device.The device history records for process work order (pwo) were reviewed.The assembly order (ao) was reviewed.There were relevant defects noted in the manufacturing and/or final quality control checklist records.Additional comments: the photo sent by the customer for evaluation suggests improper assembly-positioning of needle/wire link.However the cups' assembly could not be evaluated and therefore the evaluation and root cause is inconclusive.Investigation conclusion: the supplier provided the following: although the customer provided a photo of the device, the conclusions are based on the visual and functional evaluation of the returned device.The condition of the returned device was not able to establish a conclusive root cause.The instructions for use product inspection: "beginning at handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Note: exercising the handle while the forceps is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura biopsy forceps with spike are subjected to a visual inspection and functional testing to ensure device integrity.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 remote.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.

Manufacturer Narrative

Information regarding ec method code desc - incomplete device returned (4116).Investigation evaluation: images with the returned device.The images were taken when the device was in the patient.One image, the forceps are open and the proximal end of the spike is sticking out the side of the device.The second image is of the device closed and the proximal end of the spike is sticking out the side of the device.The pictures confirm the customer¿s difficulty removing the device from the endoscope.The device was returned with the distal end cut off, and the distal end was not included with the returned device.The device handle was manipulated and one of the wires inside the device sticks out when opening.There were no other anomalies detected.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 device was returned to the supplier.The supplier provided the following.Visual evaluation: no defects were noted to the assembly handle.The device was returned with the outer sheath completely severed approximately 228.6 cm distal from the nose cap.The cup's assembly could not be evaluated due to the condition of the device.Functional evaluation: the handle was manipulated and the control wire extended and retracted as designed.The cup's assembly could not be evaluated due to the condition of the device.The device history records for process work order (pwo) were reviewed.The assembly order (ao) was reviewed.There were relevant defects noted in the manufacturing and/or final quality control checklist records.Additional comments: the photo sent by the customer for evaluation suggests improper assembly-positioning of needle/wire link.However the cups' assembly could not be evaluated and therefore the evaluation and root cause is inconclusive.Investigation conclusion: the supplier provided the following: although the customer provided a photo of the device, the conclusions are based on the visual and functional evaluation of the returned device.The condition of the returned device was not able to establish a conclusive root cause.The instructions for use product inspection: "beginning at handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Note: exercising the handle while the forceps is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura biopsy forceps with spike are subjected to a visual inspection and functional testing to ensure device integrity.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 BIOPSY FORCEPS WITH SPIKE
• Type of Device: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10555604
• MDR Text Key: 207617880
• Report Number: 1037905-2020-00392
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002560741
• UDI-Public: (01)00827002560741(17)230316(10)W4331010
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2023
• Device Model Number: G56074
• Device Catalogue Number: DBF-2.4-230SP-20-S
• Device Lot Number: W4331010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS GASTROSCOPE, UNKNOWN MODEL; OLYMPUS GASTROSCOPE, UNKNOWN MODEL