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

Model Number	G21860
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The photos indicate the latch remains in a raised position, which would prevent the ratchet system from working properly.The lot number and label in the photos provided match the lot number of the report.The stationary handle is attached in the photo provided, but has been unscrewed from the device prior to the product's return.Further evaluation of the returned product indicates the gold coating on the stationary handle appears slightly worn.As in the photos provided, the ratchet is no longer functional since the latch remains in a raised position.The frame of the device is not skewed.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.After adjusting the spring wire and the latch/ratchet, the device now only allows 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 or Problem Description
In preparation for a demonstration, the distributor representative selected a cook soehendra lithotriptor handle.The distributor representative performed a training to the user facility on how to use the soehendra lithotriptor handle (slh-1).During the training, the distributor representative operated the device and found that the handle did not work properly.The component, next to the ratchet, was not in the right position.Additional information was received on 06/12/2018: this soehendra lithotriptor handle (slh-1) was stock and sold together with a cook conquest ttc lithotriptor cable (ttcl-10) to the hospital.The failure happened on a trial use, before the academic meeting live operation demonstration.In the trial use, the doctors and nurses wanted to practice the lithotripsy procedure, and the reverse rotating stop was found not in normal function.Before the trial, the slh-1 handle was in its original package, unopened.They don't know why the gold coating was slightly worn, this may because of improper store or delivery condition, as this product, even in the intact package, has been shown to several customers before selling it.

• Brand Name: SOEHENDRA LITHOTRIPTOR HANDLE
• Common Device Name: LQC, LITHOTRIPTER, BILIARY MECHANICAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7590846
• Report Number: 1037905-2018-00248
• Device Sequence Number: 1623887
• Product Code: LQC
• UDI-Device Identifier: 00827002218604
• UDI-Public: (01)00827002218604(17)200425(10)W3858196
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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
• Operator of Device: Other
• Device Model Number: G21860
• Device Catalogue Number: SLH-1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/12/2018
• Device Age: 13 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1