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U.S. Department of Health and Human Services

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

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WILSON-COOK MEDICAL INC SOEHENDRA LITHOTRIPTOR HANDLE; LQC, LITHOTRIPTER, BILIARY MECHANICAL Back to Search Results
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.
 
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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 Key17107141
MDR Text Key316965115
Report Number1037905-2023-00293
Device Sequence Number1
Product Code LQC
Combination Product (y/n)N
Number of Events Reported1
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 NumberSLH-1
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 05/17/2023
Initial Date FDA Received06/12/2023
Supplement Dates Manufacturer Received06/21/2023
Supplement Dates FDA Received07/13/2023
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 Number1
Treatment
SCOPE, UNKNOWN MAKE AND MODEL
Patient Age86 YR
Patient SexFemale
Patient Weight50 KG
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