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

Catalog Number SLH-1

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently in progress.A follow-up report will be sent following the completion of the investigation.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure to remove a bile duct stone, the physician used a soehendra lithotriptor handle (slh-1).During the bile duct stone extraction, the basket became entrapped, so the user used the slh-1 with the cook conquest ttc lithotriptor cable with adapter (ttcl-1) to resolve the entrapment.After the procedure, the user removed the ttcl-1 from the slh-1 for cleaning and found out that the ratchet (of the slh-1) was unable to function.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure to remove a bile duct stone, the physician used a soehendra lithotriptor handle (slh-1).During the bile duct stone extraction, the basket became entrapped, so the user used the slh-1 with the cook conquest ttc lithotriptor cable with adapter (ttcl-1) to resolve the entrapment.After the procedure, the user removed the ttcl-1 from the slh-1 for cleaning and found out that the ratchet (of the slh-1) was unable to function.Additional information received on 09 november 2020 states the ratchet did not function immediately post use.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

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.Further evaluation of the returned product indicates the gold coating on the stationary handle appears worn, and the top bar of the handle is also bent.The central bar shows signs of wear where the basket wrapped around.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: a review of the complaint history was conducted.The likelihood of occurrence is considered an isolated 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.

• 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: 10781690
• MDR Text Key: 245313635
• Report Number: 1037905-2020-00467
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

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: Health Professional
• 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: 11/03/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK CONQUEST TTC LITHOTRIPTOR CABLE WITH ADAPTER; ENDOSCOPE, UNKNOWN MODEL OR MANUFACTURER