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

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

Event Date 01/26/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: 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.Mechanical lithotripsy applies a high force to the basket wires and the stone.If the stone requires a force to fracture that exceeds the tensile strength of the basket wires, breakage will occur.The ifu includes the following warning: "basket wires may fragment and/or stone impaction may occur during lithotripsy, requiring surgical intervention." 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: 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 lithotripsy, the physician used a cook fusion lithotripsy extraction basket.It was reported that the wire burst inside of the sheath.The wires were loose [drive wire broken].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: the products said to be involved were returned in a clear plastic bag.Provided with the return was 2 open pouches from the lot number provided in the report.The labels match the products returned.Device #1: our laboratory evaluation of the product said to be involved confirmed the report.The device returned with the basket assembly fully removed from the sheath.The basket portion of the assembly is damaged/misshapen.The basket assembly had detached at the proximal end of the drive wire with minimal damage sustained to the proximal end of the wires.The drive wire had become slightly unraveled at the proximal end and a kink was observed 82.7 cm proximal to the tip of the basket.There is evidence of weld at the proximal end of the cannula.Device #2: our laboratory evaluation of the product said to be involved confirmed the report.The device returned with the basket assembly fully removed from the sheath.The basket portion of the assembly is damaged/misshapen.The basket assembly had detached at the proximal end of the drive wire with minimal damage sustained to the proximal end of the wires.A white substance was observed on the device handle and on the drive wire.The drive wire had become slightly unraveled at the proximal end and kinks were observed 81.9 cm and 82.9 cm proximal to the tip of the basket.There is evidence of weld at the proximal end of the cannula.A lab meeting was held on 23 mar 2023 with quality engineering, production leadership from the metals department, and manufacturing engineering.The cover plate and t-nut were removed from the handle on both devices.Evidence of the torquing process on the cannulas was verified.The proximal weld of the cannula of both devices was verified.In response to an identified manufacturing issue, the torque on the devices was reassessed.Upon visual inspection the deformation on the cannulas, 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 both of the devices are 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 devices confirmed the cannula 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.

Manufacturer Narrative

Investigation evaluation: the products said to be involved were returned in a clear plastic bag.Provided with the return were 2 open pouches from the lot number provided in the report.The labels match the products returned.Device #1: our laboratory evaluation of the product said to be involved confirmed the report.The device returned with the basket assembly fully removed from the sheath.The basket portion of the assembly is damaged/misshapen.The basket assembly had detached at the proximal end of the drive wire with minimal damage sustained to the proximal end of the wires.The drive wire had become slightly unraveled at the proximal end and a kink was observed 82.7 cm proximal to the tip of the basket.There is evidence of weld at the proximal end of the cannula.Device #2: our laboratory evaluation of the product said to be involved confirmed the report.The device returned with the basket assembly fully removed from the sheath.The basket portion of the assembly is damaged/misshapen.The basket assembly had detached at the proximal end of the drive wire with minimal damage sustained to the proximal end of the wires.A white substance was observed on the device handle and on the drive wire.The drive wire had become slightly unraveled at the proximal end and kinks were observed 81.9 cm and 82.9 cm proximal to the tip of the basket.There is evidence of weld at the proximal end of the cannula.A lab meeting was held on 23 mar 2023 with quality engineering, production leadership from the metals department, and manufacturing engineering.It was found that the devices were manufactured to specification.Evidence of the torquing process on the cannulas was verified.The proximal weld of the cannula of both devices was verified.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 devices confirmed the report of drive wire breakage during lithotripsy.Mechanical lithotripsy applies a high force to the basket wires and the stone.If the stone requires a force to fracture that exceeds the tensile strength of the basket wires, breakage will occur.The ifu includes the following warning "basket wires may fragment and/or stone impaction may occur during lithotripsy, requiring surgical intervention." 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: 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.

• 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: 16404102
• MDR Text Key: 310086399
• Report Number: 1037905-2023-00069
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482774
• UDI-Public: (01)10827002482774(17)251012(10)W4645308
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• 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: W4645308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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 TJF-1-190.