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

Catalog Number FS-LXB-3X6

Device Problems Nonstandard Device (1420); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

During an ercp for stone removal, the physician used a cook fusion lithotripsy extraction basket.It was reported that the user attempted to remove stone after lithotripsy but discovered the basket could not be retracted completely once the handle was pulled to the limit, and the stone was stuck inside basket.The user shook the handle several times to release the stone from basket to retract the device from patient but discovered the basket still could not be retracted into sheath.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

The investigation is ongoing.A follow up mdr will be submitted within 30 days of submission of this report.

Manufacturer Narrative

The investigation is ongoing.A follow-up mdr will be submitted within 30 days of submission of this report.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a white plastic bag.The lot number provided with the return matches this report.Included with the return was an open pouch from an olympus extraction basket, this is believed to be from the replacement device mention in the patient/event info - notes.Our evaluation of the product said to be involved confirmed the report.The device returned with the handle in the "retracted" position with the basket fully extended from the sheath.The basket responds to handle manipulation and when advanced extends further exposing a portion of the drive wire measuring 9.4 cm from the distal coil spring assembly to the proximal portion of the basket.The length from the proximal end of the orange y-body to the distal tip of the coil spring assembly measured within specifications for this device.The basket was pulled from the distal end, and it was able to be removed from the sheath.Slight damage was noted at the proximal end of the basket assembly wires under magnification.The cover plate and t-nut were removed from the handle to evaluate if the cannula had been torqued properly.Upon visual inspection the deformation on the cannula, while present, was not sufficient when compared to a "known" good part.This indicates insufficient force applied during the torquing process.This is a likely cause for the drive wire detachment and the device is therefore, considered nonconforming.To further investigate, finished device manufactured by the same operator using the same equipment was pulled from the shelf stock and tested to determine if the tensile force was within specification.The testing showed 10 out of 13 devices did not meet the requirement minimum tensile value.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 returned device confirmed cannula and drive wire was insufficiently torqued during the manufacturing process, leading to drive wire detachment.Production management and the department team leads were notified of this occurrence.A notification of operator related complaint form was provided to production management to make them aware of an operator related complaint and an operator retraining has been completed.Additionally, a capa has been initiated in an effort to reduce drive wire detachment during lithotripsy.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 corrective action has been initiated in an effort to reduce occurrences of this nature.This product is 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.

• 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: 16672918
• MDR Text Key: 312608590
• Report Number: 1037905-2023-00150
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482781
• UDI-Public: (01)10827002482781(17)250721(10)W4619651
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-LXB-3X6
• Device Lot Number: W4619651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• 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 290 ENDOSCOPE