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 Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the photos provided shows the cup housing detached from the sheath and extended.The other photo shows the cups cut from the sheath.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the cups/housing separated from the coiled catheter.One (1) of the drive wires is missing, and the welds on the forceps housing are present however they are not center in the proximal end of the fork.Additionally, there are two (2) welds present on the coiled catheter.No other anomalies detected with the device.The forceps will be sent to the supplier for further evaluation.The supplier provided the following: "one device from the reported event was returned inside of a zip type bag with proof of decontamination.The forceps was visually evaluated.The customer reported that the device was cut in order to remove the device from the endoscope.With the tip no longer attached to the coil cable, one would have to cut the two length wires to remove the tip from the rest of the device.This would result in the coil cable and handle end of the device being separated from the tip and two small pieces of wire.However, only one (1) of the small piece of wire was returned.The three (3) wire ends that were returned appear to have been clearly cut.The tip is no longer attached to the coil cable.The tip has extensive damage, one (1) cup is bent and twisted.There is evidence that the tip was previously attached to the coil cable.The weld spots on the coil cable are clearly defined.When examining the tip forks, it was also noted that the weld spots are out of location.A functional evaluation is not possible; the device was cut prior to the return of this device.The evaluation confirmed that the device was cut prior to being returned.The tip is badly damaged and is no longer attached to the coil cable.One (1) of the small pieces of wire was not returned.The weld was not in the proper location.The device history records were reviewed.There were no relevant defects noted." 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 condition of the device received confirmed that the forceps were damaged.The evaluation determined that the weld location was not correct.The operators involved will be advised of the complaint.Prior to distribution, all captura pro 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 remote.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.They went down [the endoscope with the device].They tried to biopsy the side of the stomach wall.Then, the forceps bent.They could not get it back through the endoscope through the channel.They had to pull the endoscope out with the device.They then had to cut the tip of the forceps off to get it to exit the accessory port on the endoscope." there was no reportable information at this time.The device was evaluated on 30-may-2019: there was a drive wire missing.Additional information was received on 04-june-2019: the customer stated nothing was left in the patient.From the photo it is inconclusive if anything is missing.A section of the device did not remain inside the patient¿s body.A portion of the drive wire is missing, however the location is unknown.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 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: 8729277
• MDR Text Key: 152097762
• Report Number: 1037905-2019-00349
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002476929
• UDI-Public: (01)00827002476929(17)220320(10)W4194094
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2022
• Device Model Number: G47692
• Device Catalogue Number: BF-2.2S-230SP-20
• Device Lot Number: W4194094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2019
• 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