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

Catalog Number DBF-2.4SN-160SP-20-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: 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.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, but the cups would not close.The device was sent back to the supplier for evaluation.The supplier provided following evaluation: one device from the reported event was returned in a zip type bag with proof of decontamination.Evaluation of the returned device was performed.The device was tested for "would not open/close." during functional testing, with the device coiled in two (2), 8" loops, it was confirmed that the device would not operate properly when the handle was manipulated.The device opens but does not close.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 of "would not close" was confirmed.Failure was due to a broken solder joint.The device history records were reviewed.The assembly order for this lot was manufactured in april 2017.No relevant defects were noted in the records.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 "forceps cups will open but will not close" issue experienced by the customer was confirmed and the root was determined to be a broken solder joint.They are currently working on improvements to create a more robust soldering process to prevent solder joints from breaking.The root cause is a butt joint was 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.In addition, a corrective action has been initiated to reduce occurrences of cups open/close difficulties for disposable forceps.The product said to be involved is included in the scope of the corrective actions.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 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.A corrective action has been initiated in an effort to reduce occurrences of this nature.This product was included in the scope of this corrective action.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 biopsy procedure, the physician used a cook captura serrated forceps with spike.The device was used for upper endoscopy.The physician attempted to open the cup after advancing the device to the target site in the stomach.However, because the cup would not open/close, it was changed with another cook captura serrated forceps with spike and the procedure was completed with the replacement device.There have been no adverse effects to the patient reported.The following was received on (b)(6) 2017: the cups would not open initially.The device was evaluated on 09/01/2017.The cups would open, but they would not close.

• 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: 6893222
• MDR Text Key: 89385359
• Report Number: 1037905-2017-00605
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 00827002561298
• UDI-Public: (01)00827002561298(17)200516(10)W3866783
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBF-2.4SN-160SP-20-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2017
• 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