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

Model Number G21860

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.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.The supplier indicated the spring wire and the latch/ratchet could be readjusted to only allow rotation in the counter-clockwise direction as intended.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: a definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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.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 and this represents an unusual occurrence.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

In preparation for a procedure, the user selected a cook soehendra lithotriptor handle.This is a demonstration set.During an in-service, after showing how to release the basket's wire, the ratchet was not working anymore (there was no reportable information at this time).Additional information was received on 16-nov-2018: the lithotripsy handle is supposed to move in one direction when we crank the handle.After we break the ¿pseudo stone¿, we can use the quick release ratchet to remove the basket from the handle.In this case, after using the quick release ratchet, the spring came out of its position causing the handle to move in both directions when we cranked [the handle].We tried to fix the spring back to its original position but it still will not work.This occurred during a product demonstration; a patient was not involved.

• 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
• 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: 8151616
• MDR Text Key: 130658760
• Report Number: 1037905-2018-00579
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 00827002218604
• UDI-Public: (01)00827002218604(17)181116(10)W3649996
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/16/2018
• Device Model Number: G21860
• Device Catalogue Number: SLH-1
• Device Lot Number: W3649996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1