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

Model Number G22776

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products:concomitant products: cook conquest ttc lithotriptor cable, unknown reference part number, cook soehendra lithotriptor handle, slh-1.Continued from section e.3- initial reporter occupation: unknown.Investigation evaluation: the product was returned for evaluation and the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.

Event Description

During a lithotripsy procedure, the physician used one (1) and tested two (2) prior to use cook web extraction baskets.The wire of the basket tore close to handle while doing an emergency lithotripsy [subject of this report].The stone came out of the basket.After the procedure, the users tried to replicate the malfunction on a device of the same lot number outside the patient with the same result.When cook sales representative was there to collect the devices for return, a further check (outside patient) was tried with another basket with same lot number.The wires tore as well [also subject of this report].They checked with same product of another lot number, but as well the wires tore [see related emdr 1037905-2019-00305].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.

Manufacturer Narrative

Concomitant products: cook conquest ttc lithotriptor cable, unknown reference part number; cook soehendra lithotriptor handle, slh-1.Initial reporter occupation: unknown.Investigation evaluation: provided with the returned devices was a microlabel from the lot number provided in the report.The label matches the product returned.Three (3) baskets for this report and one (1) basket for the related report 1037905-2019-00305 were included in the return, as well as two (2) basket handles, two (2) basket sheaths, a loose section of drive wire, and a cook conquest ttc lithotripter cable.Because it was unknown which basket handle and sheath belonged to which basket, a handle and sheath were arbitrarily chosen to be included in this report and the other handle and sheath is included in related 1037905-2019-00305.The loose section of drive wire and the conquest ttc lithotripter cable are included in this report.For the first returned basket, our evaluation confirmed the report.A section of the distal end of the basket approximately 178.6 cm long was included in the return.The drive wire was broken and frayed at the proximal end of the returned portion of the device.The basket was misshapen.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.For the second returned basket, our evaluation confirmed the report.A section of the distal end of the basket approximately 181.4 cm long was included in the return.The drive wire was broken and frayed at the proximal end of the returned portion of the device.The basket was misshapen.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.For the third returned basket, our evaluation of the product said to be involved confirmed the report.A section of the distal end of the basket approximately 174.4 cm long was included in the return.The drive wire was broken and frayed at the proximal end of the returned portion of the device.The basket was misshapen.The basket tip was covered in a yellow/orange substance and fibers.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The handle had approximately 2.4 cm of wire at the distal end where it was cut for lithotripsy.The sheath was approximately 217.2 cm long with kinks throughout and contained clear fluid.The loose wire section of drive wire was approximately 45.8 cm long and was fraying at the ends and had kinks throughout.The cook conquest ttc lithotripter cable had minor kinks and white discoloration on its exterior.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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use for this device includes the following: "surgical intervention may be required if impaction occurs." the instructions for use of the sohendra lithotriptor handle warns, "due to the varying compositions of biliary stones, stone fracture may not be possible.If the stone cannot be fractured, continued rotation of the handle may cause the basket wire to break, requiring surgical intervention." prior to distribution, all the web 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: 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 Description

During a lithotripsy procedure, the physician used one (1) and tested two (2) prior to use cook web extraction baskets.The wire of the basket tore close to handle while doing an emergency lithotripsy [subject of this report].The stone came out of the basket.After the procedure, the users tried to replicate the malfunction on a device of the same lot number outside the patient with the same result.When cook sales representative was there to collect the devices for return, a further check (outside patient) was tried with another basket with same lot number.The wires tore as well [also subject of this report].They checked with same product of another lot number, but as well the wires tore [see related emdr 1037905-2019-00305].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: THE WEB EXTRACTION BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8667618
• MDR Text Key: 152698491
• Report Number: 1037905-2019-00304
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002227767
• UDI-Public: (01)00827002227767(17)211220(10)W4159711
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2021
• Device Model Number: G22776
• Device Catalogue Number: WEB-2X4
• Device Lot Number: W4159711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE, UNKNOWN MODEL.
• Patient Age: 94 YR