MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY SOFT WIRE BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Model Number	G57271
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
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 includes the following: "surgical intervention may be required if stone impaction and/or basket fragmentation occurs.If a stone cannot be removed endoscopically with this basket, the soehendra lithotriptor may be used with select memory soft wire baskets (see package label) to mechanically crush stone and aid in removal.Due to mechanical pressure generated with soehendra lithotriptor, basket fragmentation and/or stone impaction in common bile duct may occur and require surgical intervention.Risk of basket fragmentation or stone impaction must be weighed against potential benefit of using lithotriptor." prior to distribution, all memory soft wire 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: 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 retrograde cholangiopancreatography (ercp) , the physician used a memory soft wire basket.During the procedure, a stone in the bile duct needed to be lithotripter.The handle of the msb-2x4-d was cut off and the sheath was removed.Wires were pulled into the cook ttcl-10 (lithotriptor cable) and were clamped onto to the slh-1(soehendra lithotriptor handle).Ttcl-10 was connected to the slh-1 via luerlock connection.The assistant began to crack the stone with single and short turns of the slh-1.After every turning movement she waited a second and made the next.After a while, the wire of the msb cracked instead of the stone.The basket was still in place and could not be retrieved by the endoscopic department.Patient was brought into the or theatre and basket was removed via surgery.Clarification was received that the wires did not rip at the tip or at the handle.They ripped inside of the conquest ttcl-10 [basket drive wires in the ttcl].It was also reported that the surgery was not planned [as part of the original treatment].The patient is (b)(6) years old.Her general constitution is beyond lower limits.The surgery has not been a positive effect on this.The physician pointed out that she is stable now but she had severe issues due to this extra procedure a section of the device did remain inside the patient¿s body.Surgery was necessary to remove the basket.According to the initial reporter, the patient did experience adverse effects due to this occurrence.

• Brand Name: MEMORY SOFT WIRE BASKET
• Common Device Name: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11982037
• Report Number: 1037905-2021-00246
• Device Sequence Number: 19624552
• Product Code: FFL
• UDI-Device Identifier: 00827002572713
• UDI-Public: (01)00827002572713(17)220926(10)W4265996
• Combination Product (Y/N): N
• PMA/510(K) Number: K902170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2022
• Device Model Number: G57271
• Device Catalogue Number: MSB-2X4-D
• Device Lot Number: W4265996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE, OLYMPUS, TJF-160VR SERIENNUMMER 2701656; JAGWIRE, GUIDEWIRE; SLH-1, SOEHENDRA LITHOTRIPTOR HANDLE; TTCL-10, CONQUEST TTC LITHOTRIPTOR CABLE
• Outcome Attributed to Adverse Event: Required Intervention