MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET; FFL, URETAL STONE DISLODGER

Catalog Number MB-35-3X6-8

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.Investigation evaluation: our photo and laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket completely extended out of the catheter lumen.Two (2) of the wires on the basket had broken loose from the proximal end of the basket but were still attached at the distal end of the basket.The basket extended and retracted freely with no sign of resistance, though the wires that detached remained outside of the catheter lumen.A silver fiber-like substance was detected near the proximal end of the basket and liquid was observed in the catheter.A meeting with production leadership was held, and the proximal tip of the wires were examined.It was determined that the wires had been damaged by the buff process.No part of the device was missing.No other anomalies were detected.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: it was confirmed that the device was broken due to damage on the basket wires caused by the buff process.This occurred due to operator error.Production management and the department team leads were notified of this occurrence.Additionally, a notification of operator related complaint form was provided to production management to make them aware of an operator related complaint.Prior to distribution, all memory ii double lumen extraction baskets 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: 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 Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a memory ii double lumen extraction basket.The user captured the stone with the device and pulled the device toward the duodenal papilla.The user detected that the basket wire was broken [subject of report] after pulling the device out of duodenal papilla.The user changed to another one of the same devices 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 this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: MEMORY II DOUBLE LUMEN EXTRACTION BASKET
• Type of Device: FFL, URETAL STONE DISLODGER
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 10553285
• MDR Text Key: 207531297
• Report Number: 1037905-2020-00389
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002247373
• UDI-Public: (01)10827002247373(17)220322(10)W4195243
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2020

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: 03/22/2022
• Device Catalogue Number: MB-35-3X6-8
• Device Lot Number: W4195243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, UNKNOWN MODEL AND MANUFACTURER
• Patient Age: 77 YR