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

Model Number G47692

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved determined that the cups were misaligned.During a functional test, the handle was manipulated, and the cups would open and close.There was no resistance felt in the handle when actuating the cups.However, when the cups were closed the teeth did not mesh completely on any side.The teeth were also visually examined from the front and found to not be meshing completely.The cups are potentially misaligned.The device was not functionally tested down an endoscope due to the condition it was returned in.The catheter is slightly damaged near the distal end of the handle.The material looks fatigued and has some slight white marks where the plastic was possibly bent.No other anomalies were detected with the device.The device was sent back to the supplier for a full evaluation.The supplier provided the following evaluation: one device was returned in a zip type bag with proof of decontamination.Visual evaluation: the forceps (bf-2.2s-230sp-20, lot w4171274) was visually evaluated.The cup tang is bent and therefore the cup teeth do not align.There is minor damage to the coil cable near the handle which is not related to this failure.No other abnormalities were detected.Functional evaluation: the device was functionally evaluated.To simulate the worst cast tortuous path the device was coiled in three (3), eight (8) inch loops.When the handle was manipulated the device opened and closed without friction however the cups did not close properly, the cup teeth are misaligned.One of the cup tangs is bent causing the teeth to not properly align, misaligned cups.Unable to determine when or how the cup became bent.No details were provided on the use of the device.The condition of the device is consistent with extreme forces.A root cause could not be determined.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 user's complaint that the 'device was defective' was confirmed.The assignable cause was not determined.All devices receive a 100% inspection prior to release.The instructions for use (ifu) includes the following to ensure proper use of the device: "beginning at the 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.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forcep is coiled may result in damage to the performance characteristics of the forceps." "forceps cups must remain closed during introduction into, advancement through, and removal from endoscope.If cups are open, damage to forceps and/or endoscope may occur.Gentle pressure must be used when operating handle of forceps.Excessive pressure will result in rigidity of the forceps, which may damage forceps and/or endoscope." "with cups closed, insert forceps into accessory channel.Note: keep end of forceps extending from accessory channel straight at all times.Allowing forceps to hang from accessory channel may cause damage to forceps." "maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site." prior to distribution, all captura pro¿ biopsy forceps 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 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 an endoscopic procedure, the physician used a cook captura pro¿ biopsy forceps with spike.The forceps were defective.Per the cook area representative, there is no further information available.There was no reportable information at this time.The device was evaluated on 21-aug-2019 and the forcep cups were found to be potentially misaligned.Our attempt to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

• 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: 9012489
• MDR Text Key: 158134958
• Report Number: 1037905-2019-00536
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002476929
• UDI-Public: (01)00827002476929(17)220131(10)W4171274
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2022
• Device Model Number: G47692
• Device Catalogue Number: BF-2.2S-230SP-20
• Device Lot Number: W4171274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2019
• 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