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

Catalog Number DBF-2.4SN-230SP-40-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open bag.The lot number said to be involved was not provided in the return.Our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, the device was functionally tested.When the handle of the device was manipulated the forceps cups will open, but they will not close.Hen the handle was exercised to open, there was some delay.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) endoscope.The endoscope was put in a torturous path.When the handle was manipulated the device would open slightly, but the cups would not close.When the scope was in a straight gi position, the cups would slightly open, but the cups would not close.The device was sent back to the supplier for evaluation.The supplier provided the following evaluation: one device from the reported event was returned in a zip type bag with proof of decontamination.The device was tested for "open / close." during functional testing, with the device in three (3) 8" loops, it was confirmed that the device would not operate properly when the handle was manipulated.The device does not close or open.Upon further investigation and disassembly of the device tip, it was noted that the device has a butt joint that has broken at the solder connection.The reported defect was confirmed.The device history records could not be reviewed due to the supplier lot number not being provided by the complainant.A review of the device history record could not be conducted because the lot number was not provided.Evaluation conclusion: the customer experienced issue of "would not open or close" was confirmed; 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 state the following 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 forcep 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

During an esophagogastroduodenoscopy (egd), the physician used a cook captura serrated forceps with spike.The user was in the duodenum taking random biopsies.The first biopsy was fine.They placed the forceps back down the endoscope, and the forceps broke when trying to open [subject of this report].They would not open or close.The forceps were removed, and they used another device to complete the procedure with no issues or harm to the patient.When the cook sales representative was at this facility, they gave him the device and told him this is the second forceps device that failed [subject of this report].The first failure occurred approximately two (2) to three (3) weeks prior and was not reported [to cook].The user involved in this procedure was out of the office at the time of the cook sales representative visit and the exact failure or further information could not be obtained [see related mdr 1037905-2017-00375].

• 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: 6633212
• MDR Text Key: 77561513
• Report Number: 1037905-2017-00374
• 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

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 Catalogue Number: DBF-2.4SN-230SP-40-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/12/2017
• 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