MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION LITHOTRIPSY EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number FS-LXB-2X4

Device Problems Fracture (1260); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

During an ercp for common bile duct stone removal, the physician used a cook fusion lithotripsy extraction basket.It was reported that the physician discovered the basket was broken during the procedure.The procedure was completed with another of the same device.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.

Manufacturer Narrative

Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photo provided we can see that the basket is broken and the metal tip is still attached to one of the 4 wires.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos and statements describing the event.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: our evaluation of the photos provided confirmed basket wire breakage.However, we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all fusion lithotripsy extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity.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.

Manufacturer Narrative

The following corrections were made to the annex codes: annex a code changed from a0414 to a040101.Annex c code changed from c0706 to c070603.Annex d code changed from d15 to d1101.Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.The photos show the distal end of the device with the basket retracted and advanced.Per the photos provided we can see that the basket wires are broken and the metal tip is still attached to one of the 4 wires.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos and statements describing the event.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: our evaluation of the photos provided confirmed basket wire breakage.However, we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.The additional information states that the scope used was an olympus jf260 (olympus jf260v).The channel size of the duodenoscope model used is 3.7 mm.The minimum required channel size for the fusion lithotripsy extraction basket is 4.2 mm.This is most likely cause for the reported occurrence.Prior to distribution, all fusion lithotripsy extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: based on the quality engineering risk assessment no corrective action is warranted at this time.This report represents an unusual occurrence.The likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• Brand Name: FUSION LITHOTRIPSY EXTRACTION BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 15571651
• MDR Text Key: 306082495
• Report Number: 1037905-2022-00556
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482774
• UDI-Public: (01)10827002482774(17)241001(10)W4521141
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-LXB-2X4
• Device Lot Number: W4521141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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
• Treatment: OLYMPUS JF260