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

Catalog Number SLH-1

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), a cook soehendra lithotriptor handle was used.The handle was used with an extraction basket made by another manufacture.The handle snapped in two.No section of the device detached inside the endoscope or patient.A second handle was used to complete the originally intended procedure and functioned properly.At this time, the basket wires broke near the patient's mouth.Due to the breakage of the basket wires, the patient was moved to surgery to complete the procedure.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the breakage of the handle but was moved to surgery to complete the procedure after the breakage of the basket wires.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: the photo provided confirmed the handle is broken.A product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.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.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.Additional comments regarding this report: based on the information provided, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: SOEHENDRA LITHOTRIPTOR HANDLE
• Type of Device: 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: 4355834
• MDR Text Key: 5220494
• Report Number: 1037905-2014-00475
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2014

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 Catalogue Number: SLH-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/13/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: OLYMPUS EXTRACTION BASKET: TYPE UNK; OLYMPUS ENDOSCOPE: MODEL UNK