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

Model Number	G21661
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: 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.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: 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 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 receiver may damage the stent receiver.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 an endoscopic procedure, the physician used a cook soehendra stent retriever.The stent retriever tip came away inside the patient [detached].The location of the detached portion is unknown.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

• 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: 9432890
• Report Number: 1037905-2019-00749
• Device Sequence Number: 2450488
• Product Code: FGE
• UDI-Device Identifier: 00827002216617
• UDI-Public: (01)00827002216617(17)200307(10)W3835254
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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 Expiration Date: 03/07/2020
• Device Model Number: G21661
• Device Catalogue Number: SSR-8.5
• Device Lot Number: W3835254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1