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

Model Number G21860

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The end of the rotating handle is loose and easily removed.The stationary handle is broken off of the body of the device.The supplier conducted a full evaluation.The ratchet mechanism is broken due to the spring being removed from the drilled hole inside the ratchet.The drilled hole shows signs of damage due to forcible removal.Signs of wear were present on the body of the device near the ratchet.The end of the rotating handle was confirmed to be disconnected but was successfully reconnected using the appropriate screw.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." 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: 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

Prior to an endoscopic procedure, the physician selected a cook soehendra lithotriptor handle.When disinfecting the handle with a wipe tissue, the metal rod located on the side came out from its position.In trying to put it back in place the handle broke.This occurred prior to patient contact; there was no impact to the patient.

• 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: 9179815
• MDR Text Key: 200260569
• Report Number: 1037905-2019-00592
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 00827002218604
• UDI-Public: (01)00827002218604(17)220306(10)W4188067
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: G21860
• Device Catalogue Number: SLH-1
• Device Lot Number: W4188067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2019
• 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