MAUDE Adverse Event Report: COOK ENDOSCOPY SOEHENDRA STENT RETRIEVER; FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	G21937
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: olympus visiglide wire guide; unknown model.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.A visual examination of the returned device shows the solder joint adhering the metal tip to the irrotational cable appears to be intact.However, the metal tip has broken.One piece remains soldered to the tip of the device, and one piece separated and was not provided with the return.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use indicates the following: "once stent is securely connected to retriever, open elevator of endoscope and slowly pull stent and stent retriever out of channel making sure wire guide is left in place." pulling too quickly on the stent with the stent retriever may damage the stent retriever.Prior to distribution, all soehendra stent retrievers are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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.
Event or Problem Description
During endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook soehendra stent retriever.Suddenly, the tip of the retriever got lost [detached].

• Brand Name: SOEHENDRA STENT RETRIEVER
• Common Device Name: FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7383406
• Report Number: 1037905-2018-00125
• Device Sequence Number: 11081170
• Product Code: FGE
• UDI-Device Identifier: 00827002219373
• UDI-Public: (01)00827002219373(17)201227(10)W4012751
• Combination Product (Y/N): N
• PMA/510(K) Number: K161203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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
• Operator of Device: Health Professional
• Device Model Number: G21937
• Device Catalogue Number: SSR-7
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/02/2018
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1