MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA SERRATED FORCEPS WITH SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number DBF-2.4SN-230SP-20-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the two products said to be involved was returned in an open bag.The lot number said to be involved was not provided in the return.Device 1 - our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, a functional test was performed.When the handle of the device was manipulated the forceps cups will open, but they will not close.Several attempts were made to close the forceps cups, but they were unsuccessful.The device was then placed down an olympus gif-q20 (2.8 mm channel) scope.The scope was put in a torturous path.When the handle was manipulated the device would open, but the cups would not close.Device 2 - our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, a functional test was performed.When the handle of the device was manipulated the forceps cups will open, but they will not close.Several attempts were made to close the forceps cups, but they were unsuccessful.The device was then placed down an olympus gif-q20 (2.8 mm channel) scope.The scope was put in a torturous path.When the handle was manipulated the device would open, but the cups would not close.When the forceps cups were opening in the scope, there was a delay.Both devices were sent back to the supplier for evaluation.The supplier provided the following evaluation: two devices from the reported event were returned in a zip type bag with proof of decontamination.The returned devices from the reported event were tested for "would not open".During functional testing, with the devices coiled into three (3) 8" loops, it was confirmed that the devices would not operate properly when the handle was manipulated.The devices open but do not close.Upon further investigation and disassembly of the device tips for device 1 and 2, respectively, it was noted both devices had butt joints that broke at the solder connection.Defects were confirmed for both devices.The lot number said to be involved was not provided for the reported event, therefore the device history records could not be reviewed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: the customer experienced issue of "would not open" was confirmed; the device opens but does not close.The device has a butt joint that has broken at the solder connection.The root cause is a butt joint with a broken control wire / link wire solder joint.The supplier is currently working on improvements to create a more robust soldering process to prevent solder joints from breaking.The instructions for use states in regards to product inspection: "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 forceps is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura 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 Description

In preparation for a procedure, the physician selected two (2) cook captura serrated forceps with spike.The facility was testing the devices away from the patient and they would not open.The handle felt loose on them.A third dbf-2.4sn-230sp-20-s was opened and used to complete the intended procedure.

• Brand Name: CAPTURA SERRATED FORCEPS WITH SPIKE
• Type of Device: FCL, FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): 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: 6647318
• MDR Text Key: 77939479
• Report Number: 1037905-2017-00402
• Device Sequence Number: 1
• Product Code: FCL
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBF-2.4SN-230SP-20-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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