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

Catalog Number MSB-2X4

Device Problem Unintended Collision (1429)

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 07/07/2017

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.A definitive cause for the reported observation could not be determined.The instructions for use (ifu) states the following: "if this device is to be used for the removal of biliary stones, contraindications include an ampullary opening inadequate to allow for the unimpeded passage of the stone and basket.¿ "assessment of stone size and ampullary orifice must be made to determine necessity of sphincterotomy.If sphincterotomy is required, all appropriate cautions, warnings and contraindications must be observed." the ifu 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.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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook memory soft wire basket.As reported to customer relations: "the stone was captured in the common bile duct.The basket got stuck because the facility did not perform any lithotripsy.Once the facility realized the stone was stuck, they called the district manager to inquire if the device would break if they manually removed it.The facility decided to cut the handle off the basket, they took the sheath off of the wires and removed the endoscope; leaving the wires hanging out of the patients mouth.At this point, the procedure was finished.The patient was sent to the operating room for a surgery consult for removal of the device.When the district manager (dm) asked the facility if they have a cook soehendra lithotriptor or if they used a lithotriptor, the facility indicated, no." additional information received on (b)(6) 2017: the device (basket) had partially captured a very large common bile duct stone.They did not have a mechanical lithotriptor to crush the stone and they could not dislodge the stone out of the basket.The device was surgically removed.The device did not malfunction.Additional information received by the dm: i have an appointment with the customer on (b)(6) 2017 to go over mechanical lithotripsy so they will have the tools they need to crush stones in the common bile duct.The patient went to surgery and is doing fine post surgery with the basket and stone removed successfully.

• Brand Name: MEMORY SOFT WIRE 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: 6756650
• MDR Text Key: 81489510
• Report Number: 1037905-2017-00513
• 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: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MSB-2X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2017
• Event Location: Hospital
• Date Manufacturer Received: 07/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS DUODENOSCOPE - TJF
• Patient Outcome(s): Required Intervention