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U.S. Department of Health and Human Services

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

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WILSON-COOK MEDICAL INC SOEHENDRA LITHOTRIPTOR HANDLE; LQC, LITHOTRIPTOR, BILIARY MECHANICAL Back to Search Results
Catalog Number SLH-1
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2014
Event Type  malfunction  
Event Description
During the procedure, a cook soehendra lithotriptor handle was used.The handle broke.It was observed that the screw broke which prevented its removal and replacement.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 not performed to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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 conclusions: 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 the integrity of the device is intact.The instructions for use also state: reusability of device depend 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.During cleaning, inspect integrity and function of device to determine advisability of reuse.If kinks, bends or breaks exist, do not use.Prior to distribution, all cook devices 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, LITHOTRIPTOR, BILIARY MECHANICAL
Manufacturer (Section D)
WILSON-COOK MEDICAL INC
winston-salem NC 27105
Manufacturer Contact
scottie fariole, mgr
4900 bethania station rd.
winston-salem, NC 27105
3367440157
MDR Report Key4319686
MDR Text Key5206707
Report Number1037905-2014-00457
Device Sequence Number1
Product Code LQC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K902170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 10/31/2014
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 Expiration Date04/22/2017
Device Catalogue NumberSLH-1
Device Lot NumberW3420090
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/12/2014
Device Age5 MO
Event Location Hospital
Initial Date Manufacturer Received 11/04/2014
Initial Date FDA Received11/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2014
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
ENDOSCOPE, MODEL NO.: UNK
Patient Age60 YR
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