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

Model Number G21860

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter; occupation: unknown.Investigation evaluation: the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.

Event Description

In preparation for an endoscopic retrograde cholangiopancreatography (ercp), the user selected a cook soehendra lithotriptor handle.It was reported that the physician opened the package at the preparation stage and found that the handle could not prevent backspin.The physician retracted the basket and changed to another basket which did not need a lithotriptor to complete the procedure.This occurred prior to patient contact; there was no impact to the patient.In addition, the user sustained no clinical consequence and there were no adverse effects to the user.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a clear ziploc bag.A lot number was not with the returned device.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the latch in the 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 spring wire holding down the latch appears bent as if pressed down by an external force.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A discussion of the report and a review of the device photos occurred with the supplier on (b)(6) 2022.The supplier indicated the following "the only way this unit is able to rotate backwards is if the spring is bent and it loses pressure to the pawl." 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: 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 rare.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
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 13169098
• MDR Text Key: 291248141
• Report Number: 1037905-2022-00008
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 00827002218604
• UDI-Public: (01)00827002218604(17)230106(10)W4304608
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: G21860
• Device Catalogue Number: SLH-1
• Device Lot Number: W4304608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2020
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 59 KG