MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC SOEHENDRA LITHOTRIPTOR HANDLE; LQC, LITHOTRIPTER, BILIARY MECHANICAL

Catalog Number SLH-1

Device Problems Break (1069); Fracture (1260)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

During lithotripsy to remove a bile duct stone, the physician used a cook soehendra lithotriptor handle.It was reported that the handle broke during procedure.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: a product evaluation was performed only by the picture provided with this report because the product said to be involved was not provided to cook for evaluation.A photo of the lot number was not provided.The photo shows the device where it can be observed that the bottom crossbar has broken/ bent, confirming the report.It was also observed that the adapter is missing/ disconnected from the broken/bent bar in the photo.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: our evaluation of the photo provided confirmed the report.However, 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.Prior to distribution, all soehendra lithotriptor handles are subjected to a visual inspection and functional testing to ensure device integrity.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.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a white plastic bag.A lot number was not provided with the returned device.The photo provided shows the device where it can be observed that the bottom crossbar has broken/ bent, confirming the report.It was also observed that the adapter is missing/ disconnected from the broken/bent bar in the photo.A photo of the lot number was not provided.Our laboratory evaluation of the product said to be involved confirmed the report of "broken handle".The bottom crossbar has bent and broken at the threaded hole in the center of the bar the adapter is missing/ disconnected from the broken/bent bar and was not provided in the return.The threads in the hole on the bottom crossbar is otherwise intact.The middle cross bar has bent slightly as well.The device was returned with the latch in the lowered position.The center bar is able to rotate counterclockwise and is unable to rotate clockwise as designed.The spring wire holding down the latch appears intact.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A supplier meeting was held 12jul2023.The deformation of the crossbars is indicative of deformation due to force being applied.This force on the bottom crossbar during use lead to the fracture observed at the center, allowing the adapter to be removed from the threaded hole.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: our laboratory evaluation of the product said to be involved confirmed the report of "broken handle".The condition of the device indicates excessive force was applied leading to the handle breakage.Prior to distribution, all soehendra lithotriptor handles are subjected to a visual inspection and functional testing to ensure device integrity.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
• Type of Device: LQC, LITHOTRIPTER, BILIARY MECHANICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 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: 17107141
• MDR Text Key: 316965115
• Report Number: 1037905-2023-00293
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

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
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SCOPE, UNKNOWN MAKE AND MODEL
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 50 KG