MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC CAPTURA SERRATED FORCEPS WITH SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Model Number G56128

Device Problems Device Damaged by Another Device (2915); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2022

Event Type  malfunction  

Event Description

In preparation for an endoscopic biopsy procedure in the stomach, the physician selected a cook captura serrated forceps with spike.Before introducing the clamp [forceps] into the operator channel of the endoscope, the gastroenterologist realized that the clamp had a defect.When the clamp is closed, a metal piece protrudes.The physician switched to another biopsy forceps.A photo provided depicts a gap in the cups when the cups are closed.This occurred prior to patient contact; there was no impact to the patient.In addition, the user sustained no clinical consequence and there were no adverse effects to the user.

Manufacturer Narrative

Investigation evaluation: a product evaluation was performed only by the picture provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photo provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photos describing the event.A photo of the lot number was not provided.The photo provided shows the distal end of the device, and the forceps are in a closed position, with the jaws not completely meshed together, and the proximal end of the spike sticking out the side of the device.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.

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a clear plastic bag with an open pouch from the lot number provided in the report.The label matches the product returned.The photo provided shows the distal end of the device, and the forceps are in a closed position, with the jaws not completely meshed together, and the proximal end of the spike sticking out the side of the device.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned in the coiled position with the forceps cups closed.During a visual examination, it can be seen that when the cups are fully closed the proximal end of the spike is protruding from the cup housing.The cups open and close when the handle is manipulated.Under visual magnification, it can be seen that the cups do not mesh together fully and the holes on the cups of the forceps are offset slightly (i.E.Misaligned).The device was not function tested in the scope due to the condition of the returned device.The rest of the distal end components had no anomalies or damage.The device was returned to the supplier for further evaluation and the following was provided, "device was received with jaws in the closed position.The tail of the needle [spike] was observed to be protruding out of the fork.The cups are slightly misaligned when in the closed position.It was also noted that the needle was not straddled by the link wires.No damage visible to the coil cable, coating or handle components.Device was actuated in the u-bend and 2-coil positions, and in both positions the jaws opened and closed freely." the device history records were reviewed and a relevant defect was noted.The device history record for the lot# said to be involved was reviewed.The same manufacturing nonconformances identified during the device evaluation was identified during the device history record review.Based on the review it is possible nonconforming product was released into distribution.A field action assessment was completed to determine if field action is required.In addition production was notified in an effort to heighten their awareness.Investigation conclusion: our laboratory evaluation of the product confirmed the report.The supplier provided the following, "the reported issue of "needle out of the fork" was confirmed and it was determined that the root cause of this issue is due to human error.When assembled per manufacturing instructions, it should be assembled with the link wires straddling the needle.Steps in the assembly procedure are clear and concise; it instructs the operator to perform a 100% visual inspection to "verify wire links straddle needle, are correctly installed", and to "verify cups are properly aligned and mesh correctly".The root cause for the misalignment of cups is due to the needle not being properly straddled by the link wires.The minimum acceptable pivot pin swage diameter for the returned device met the minimum requirements.When viewed under magnification, the pivot pin swage is complete and uniform in appearance.The pivot pin is straight, with no buckling.With these observations, it was concluded that the jaws were functioning properly at the time the device was assembled.Based on the findings reported in this investigation summary, it is recommended for operator training to the assembly procedure be re-performed.Root cause was determined to be human error.Operators will be advised of the complaint and retrained.Prior to distribution, all captura biopsy forceps with spike are subjected to a visual inspection and functional testing to ensure device integrity.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 SERRATED FORCEPS WITH SPIKE
• Type of Device: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• 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: 15744691
• MDR Text Key: 306902882
• Report Number: 1037905-2022-00615
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G56128
• Device Catalogue Number: DBF-2.4SN-160SP-S
• Device Lot Number: W4612443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1