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

Model Number	G21860
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook msb-2x4 memory soft wire basket, cook ttcl-1 conquest ttc lithotripter cable.Investigation evaluation: a product evaluation was performed only by the picture provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photo provided we cannot complete a full evaluation.The photo shows a slh-1 device where the stationary handle has broken off of the proximal bar and the rotating handle has broken off of the central bar.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photo provided and the statements describing the event.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.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 also states: "reusability of device depends in a 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: 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
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook soehendra lithotriptor handle (slh-1).The user advanced the cook memory soft wire basket (msb-2x4) device into lower segment of common bile duct and fetched the stone.But the stone could not go through the duodenal papilla.Then they introduced the basket to middle part of common bile duct and cut the handle part of the basket.Pull out the plastic sheath.They advanced the cook conquest ttc lithotripter cable (ttcl-1) along the wire of the basket.Then rotated the handle of slh-1 to crush the stones.But, the handle of the slh-1 was detached [broke].Replace [with a] new device to finish the procedure.
Additional Manufacturer Narrative
Concomitant medical products: cook msb-2x4 memory soft wire basket.Cook ttcl-1 conquest ttc lithotripter cable.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The stationary handle has broken off of the proximal bar and the rotating handle has broken off of the central bar.The supplier conducted a full evaluation.In addition to the broken handles, the middle of the central bar appears worn and the frame of the device is a bit skewed.The ratchet and lever arm on the ratchet also appear to be a bit skewed.The central bar rotates counter-clockwise as intended; however, the ratchet on the central bar is loose allowing the bar to also rotate clockwise on occasion.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 use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.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 also states: "reusability of device depends in a 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: 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
• Common Device Name: LQC, LITHOTRIPTER, BILIARY MECHANICAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6731469
• Report Number: 1037905-2017-00488
• Device Sequence Number: 13726932
• Product Code: LQC
• UDI-Device Identifier: 00827002218604
• UDI-Public: (01)00827002218604(17)190321(10)W3701344
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2017

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: Health Professional
• 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: 06/26/2017
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 52