MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ACUSNARE POLYPECTOMY SNARE SOFT; FDI, SNARE, FLEXIBLE

Catalog Number SASM-1-S

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Section g: pma/510(k): k173673.The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.

Event Description

During a colonoscopy, the physician used a cook acusnare polypectomy snare soft.It was reported that while snaring cold and without cautery [off label use], the snare detached from the catheter.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; however the detached portion was removed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Photos attached show the snare head in the packaging with it detached.Other photos show endoscopic images of the snare head detached in the patient.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the device in a coiled position and the snare head was detached from the catheter.Upon further inspection under visual magnification, it could be seen that the snare head was not crimped, however it was crimped to the catheter wire.A function test was not possible, due to the condition of the device.The device was sent to the supplier for further evaluation and the following was provided, "visual evaluation of the device confirms the reported complaint that the snare is detached from the main body of the device.Visually inspecting the snare head it can be identified that the cannula connecting the snare and the drive cable is not fully crimped on the side that connects the drive wire.All other components visually satisfy requirements for a completed device.The device was dismantled to inspect the crimps for the snap pin and the push rod/drive wire subassembly as it applies to electrical current.Checking the crimp all aspects were satisfactory.Functional evaluation of the snare could not be performed due to the detached snare head.Actuation of the handle was able to confirm that the drive wire/push rod subassembly was properly crimped to the snap pin.No further functional testing performed.The reported complaint for snare detachment is confirmed.The snare head detached from the drive cable due to an insufficient crimp along the cannula that joins the snare to the drive cable.Per the process traveler operators are required to crimp the snare head to drive wire along with an additional 100% visual inspection and manual tug for each device.Additionally, tensile testing is performed on 20 snare assembly samples for every lot that is manufactured prior to moving forward with production of the remainder of the lot.It is required that the snare assembly can withstand a minimum lbf before breaking away from the cannula.The root cause of the non-conformance is human error." the device history record was reviewed.They were was manufactured september 2023.There were no relevant defects noted in the manufacturing/ fqc checklist.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: our laboratory evaluation of the device confirmed the report.The supplier provided the following, "root cause was determined to be human error.Awareness training will be performed on procedure mfg-080, specifically crimping the snare head to the drive wire." in addition, the user specified they were using the snare without an electrosurgical unit which would place additional forces on the snare to drive wire crimp potentially contributing to this failure.Use of the snare without an electrosurgical unit is against the instructions for use (ifu).The ifu states "following the electrosurgical unit manufacturer's instructions for settings, verify the desired settings and activate the electrosurgical unit.Securely connect the active cord to the device handle and electrosurgical use.Proceed with polypectomy, upon completion of the polypectomy, turn the electrosurgical unit off." prior to distribution, all acusnare polypectomy snares 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 remote.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 snare was used without an electrosurgical unit, 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.

• Brand Name: ACUSNARE POLYPECTOMY SNARE SOFT
• Type of Device: FDI, SNARE, FLEXIBLE
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 18452929
• MDR Text Key: 332595407
• Report Number: 1037905-2024-00011
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SASM-1-S
• Device Lot Number: W4773444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2023
• 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 190 SERIES COLONOSCOPE.