MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION LITHOTRIPSY EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number FS-LXB-2X4

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Perforation (2001); Tissue Damage (2104)

Event Date 07/26/2017

Event Type  Injury  

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.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.The report indicates the user applied excessive force to the basket during removal resulting in the endoscope pulling back into the stomach during stone removal.This is the most likely cause of the complaint.The instructions for use (ifu) states: "withdraw basket into sheath while maintaining entrapment.Caution: if difficulty is encountered when removing basket from duct, do not use excessive force.Moderate force may be applied by closing handle to manually fracture stone.If passage is still restricted, surgical intervention may be necessary." prior to distribution, all fusion lithotripsy extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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.Additional comments regarding this report: based on the information provided that excessive force was applied during stone removal when resistance was felt, 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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion lithotripsy extraction basket.The physician reported that the metal tip of the device cut into the stomach wall as he [was] pulling the bile duct stones out of the duct.Upon inspection of the device after the procedure, there was nothing wrong with the device.There was no sharp or jagged edges.It was intact.Clips were used to close the stomach wall area.The next day, the pt [patient] had a micro-perforation in the general area where the procedure was performed (around bile duct or duodenum).Intervention for the micro-perforation has not yet been determined.Intervention will likely be performed.The following additional information was provided from the cook area representative on 8/2/17: multiple stones were being removed (the physician stated 20 stones were removed, however this could be an overstated total).Several stones were extracted without problem, however the stones became bigger and resistance was felt.When trying to pull the stone(s) out of the bile duct the physician pulled the endoscope and basket with excessive force and the basket and endoscope were pulled back into the stomach as a result of the excessive force used.The patient was older and in her 80¿s.The cut in the stomach and the micro-perforation were separate problems.The user facility has a procedure to keep products and return to the manufacturer if a problem or issue with the device is detected.The facility inspected the device after being removed from the patient, but no signs of a defect were observed so the device was not kept.The following additional information was provided from a cook area representative on 8/17/2017: a chest tube was placed as an intervention for the micro-perforation; the patient had no additional surgeries.The micro-perforation was likely contributed from a diverticulum by the ampulla and was not caused by the cut in the stomach.The physician was unaware that the basket was lithotripsy compatible.

• Brand Name: FUSION LITHOTRIPSY EXTRACTION BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): 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: 6809778
• MDR Text Key: 83219788
• Report Number: 1037905-2017-00547
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FS-LXB-2X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/26/2017
• Event Location: Hospital
• Date Manufacturer Received: 07/28/2017
• 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: OLYMPUS DUODENOSCOPE - 180 MODEL
• Patient Outcome(s): Required Intervention