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

Model Number G56999

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: a photo was provided by the user.Per the photo, one of the forceps forks has come off from the coil cable.The forceps cups are also completely open.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the forceps cup housing bent.One of the forceps forks was not attached to the coil cable.The weld mark on the forceps fork arm was present, however it was difficult to determine if a weld was on the coiled catheter.There was damage on the distal end of the coil sheath, right below where the forceps fork arms attach.Under visual magnification, the cups were misaligned, most likely due to the forceps fork arm being detached from the coiled catheter.The forceps was sent back to the supplier for further evaluation.The supplier provided the following information: one (1) device from the reported event was returned inside of a zip type bag with proof of decontamination.The forceps was visually evaluated.There was evidence of extreme damage.The tip was mangled.One (1) fork is deformed.The other 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 both the outside and inside of the loose fork and the coil cable.The needle was bent.Because both forks are no longer attached, forceps cups alignment cannot be accurately assessed.A functional evaluation was not possible.One (1) fork was no longer attached to the coil cable and the tip was mangled.The user complaint of "piece of metal was hanging off the side of the forceps jaw during a colonoscopy" was confirmed.The tip was mangled.One fork and the needle are bent and the other fork was no longer attached to the coil cable.Due to the condition of the device, a root cause of the failure could not be determined.Both forks were originally attached to the coil cable at the time of release and shipment.The device history records were reviewed and found to be manufactured in january 2019.There were defects noted in the manufacturing and/or final quality control checklist records for weld placement, ring gauge, and misaligned cups.The relevance of the defects to the current condition of the device cannot be stated with certainty.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 'a piece of metal hanging off the side of the forcep jaw' was confirmed.The assignable cause was not determined.In its current condition, the device would not have passed final inspection prior to release and shipment.All devices are 100% functionally tested to ensure that the forceps operate freely with no hesitation, with no grinding, friction or clicking and that the cups close completely with normal closing force and that the cups are not misaligned.The forceps are visually inspected for coating/cable surface defects, weld on both sides of the fork and that the fork is attached straight in line with the cable.Prior to distribution, all capture pro¿ biopsy forceps with spike are subjected to a visual inspection 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 and this represents an unusual occurrence.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 a colonoscopy, the physician used a cook capture pro¿ biopsy forceps with spike.The user found a defective forceps.A piece of metal was hanging off the side of the forceps jaw during a colonoscopy.There was no reportable information at this time.The device was received for evaluation on 26-mar-2019.The forceps cups were 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
• Type of Device: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 8546805
• MDR Text Key: 152848291
• Report Number: 1037905-2019-00208
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002569997
• UDI-Public: (01)00827002569997(17)220109(10)W4165277
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: G56999
• Device Catalogue Number: BF-2.8SJ-230SP-40
• Device Lot Number: W4165277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2019
• 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