MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA SERRATED LARGE FORCEP-SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

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

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved determined that the forceps cups were misaligned.During evaluation, the handle of the device was manipulated and the forceps cups opened and closed fully.A visual inspection was performed under magnification and the proximal end of the spike is protruding outside of the forceps cups housing while in a closed position.When the forceps cups are in the open position, the proximal end of the spike continued to protrude outside of the forceps cups housing.When looking at the forceps cups housing from a top view, the spike does not line up between with the link wires.It was also observed that the cups were misaligned while in the closed position.It is possible that the condition of the spike is contributing to the misalignment of the cups.The device was sent back to the supplier for further evaluation.The supplier provided the follow evaluation: one (1) device from the reported event was returned in a zip type bag with proof of decontamination.The returned device was visually evaluated.No defects in the handle or catheter were noted.One (1) of the flanges, in addition to the spike, were protruding from the cups assembly.The returned device was functionally evaluated.During testing, with the device coiled in three (3), eight (8) inch loops, it was confirmed that the device did not operate properly when the handle was manipulated.The device opened as designed but did not close completely due to the protrusion of the spike.The returned device was evaluated for misalignment of the cups.It was observed that the spike was not between the link wires, which caused the spike to move to one (1) side and protrude from the cups, which caused the cups to misalign.The reported event for spike and flange protrusion from the cups as well as cups misalignment was confirmed.The cause was an assembly error during manufacturing.The device history records were reviewed and determined to be manufactured july 2018.No relevant defects were noted in the manufacturing and/or final quality control checklist 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 reported issue from the user that the "hinge was sticking out of the housing" was confirmed.It was determined that the spike was not positioned correctly between the link wires causing the flange and spike to protrude, which caused cup misalignment.The assignable cause was operator error.The operators involved will be advised of the complaint and retrained on the assembly procedure." prior to distribution, all captura serrated large forcep-spike 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 a biopsy procedure, the physician used a cook captura serrated large forcep-spike.Per the customer, "when they were taking biopsies of the gastro-esophageal (ge) junction and they were pulling the forceps out of the endoscope, they felt resistance.It appeared that the hinge was sticking out of the housing a little bit.Prior to this incident, they had taken small bowel biopsies and gastric biopsies but they did not notice a problem until they were trying to pull forceps out of the endoscope after ge junction biopsies.They noticed that something was sticking out of the housing before they did the ge junction biopsies.All intended biopsies were successfully completed with this device." there was no reportable information at this time.The device was evaluated on 01-oct-2018 and it was determined that 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 SERRATED LARGE FORCEP-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: 8009666
• MDR Text Key: 126528887
• Report Number: 1037905-2018-00500
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002560765
• UDI-Public: (01)00827002560765(17)210806(10)W4101718
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2021
• Device Catalogue Number: DBF-2.4SL-230SP-40-S
• Device Lot Number: W4101718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2018
• 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