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

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.

• 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 Key: 4319686
• MDR Text Key: 5206707
• Report Number: 1037905-2014-00457
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902170
• Number of Events Reported: 1
• 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 Date: 04/22/2017
• Device Catalogue Number: SLH-1
• Device Lot Number: W3420090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2014
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, MODEL NO.: UNK
• Patient Age: 60 YR