MAUDE Adverse Event Report: COOK ENDOSCOPY SOEHENDRA LITHOTRIPTOR HANDLE; LQC, LITHOTRIPTER, BILIARY MECHANICAL

Catalog Number SLH-1

Device Problems Mechanical Problem (1384); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: sales representative.The investigation is currently in progress.A follow-up report will be sent following the completion of the investigation.

Event Description

During a demonstration of the product, the cook sales representative used a soehendra lithotriptor handle.The soehendra lithotriptor handle (slh-1) was used with a cook conquest ttc lithotriptor cable with adapter (ttcl-1) for a demonstration to show how to use the device, but the ratchet handle (of the slh-1) became unable to function after the cook sales representative removed the ttcl-1 from the slh-1.This occurred during a product demonstration; no patient was involved.

Manufacturer Narrative

Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The latch remains in a raised position, which prevents the ratchet system from working properly.The central bar rotates smoothly counter-clockwise as intended.However, the central bar also rotates smoothly clockwise if the latch is not manually pushed down onto the ratchet gear.The supplier conducted a full evaluation.The supplier indicated the spring wire holding down the latch appears bent as if pressed down by an external force.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: the failure of the lithotriptor handle is caused by damage to the spring wire that holds the latching mechanism in place.The cause of the damage is unknown.The instructions for use state that the device is reusable as long as integrity of the device is intact."during cleaning, inspect integrity and function of device to determine advisability of reuse.If kinks, bends or breaks exist, do not use." the instructions for use caution: "reusability of device depends in large part on care of device by user.Factors involved in prolonging life of this device include, but are not limited to: thorough cleaning following instructions included in this booklet." prior to distribution, all soehendra lithotriptor handles are subjected to a visual inspection and functional testing to ensure device integrity.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: SOEHENDRA LITHOTRIPTOR HANDLE
• Type of Device: LQC, LITHOTRIPTER, BILIARY MECHANICAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10786752
• MDR Text Key: 214653313
• Report Number: 1037905-2020-00468
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: SLH-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK CONQUEST TTC LITHOTRIPTOR CABLE, TTCL-1; COOK CONQUEST TTC LITHOTRIPTOR CABLE, TTCL-1