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

Catalog Number ASM-1-S

Device Problem Material Separation (1562)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

During a colonoscopy, the physician used a cook acusnare polypectomy snare.It was reported [that] the wire was not contained within the handle.On initial grab of a polyp, closure of snare snapped at the handle and sleeve connection.The device was evaluated on 23-january-2024.The snare was fully retracted.The catheter had separated from the handle making it impossible to advance/retracted snare head [subject of report].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

Section g: pma/510(k): k173673.The product was returned to the approved supplier for evaluation and the investigation is on-going.Once additional information has been received a follow-up emdr report will be provided.

Manufacturer Narrative

Section g: pma/510(k): k173673.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.Our laboratory evaluation of the product said to be involved confirmed the report.The snare was returned fully retracted into the sheath.During visual examination, it was seen that the snare sheath had separated from the handle, thus preventing the snare from being able to advance.The device was sent to the supplier for further evaluation and the following was provided, "upon inspection of the device it was noted that the red end cap for the device was missing in the packaging provided to the reviewer.Inspection of the remaining handle components was satisfactory, with no components out of the specification, orientation, or fitment.Evaluating the snare tip there were no visual deficiencies in positioning, crimp, or exposure when the handle was actuated.Functional evaluation was limited due to the missing red cap.Without this cap there is no restricting component to hold the sheath in place and allow the drive wire to travel fully exposing the snare as the device was designed.In conclusion, the device was received with the sheath detached from the handle as stated in the original complaint, however, the device was received incomplete with the red end cap missing.Looking at the original complaint there is no mention of a missing cap.This detail is also missing from the cook evaluation.Looking at the device history record there is no designation of scrap or defects relating to red end caps.Additionally the final quality checklist has no determination of an incomplete device being rejected.Lastly, operation will not complete a full cycle without the red end cap placed in its holding fixture.Without understanding the status of the red end cap and if it was ever included in the device, a root cause cannot be assigned to the complaint." the device history records were reviewed.They were manufactured september 2023.There were relevant defects noted in the manufacturing/fqc checklists.The device history record for the lot # said to be involved was reviewed.Non-conformance's that could potentially be related to the complaint were contained in the associated dhr.The nonconformance documentation supports the affected device(s) were dispositioned appropriately prior to release of this lot.There is no evidence nonconforming product was released for distribution.In an effort to heighten awareness of the potential connection of the customers report to the current manufacturing processes production personnel were notified.Investigation conclusion: our laboratory evaluation of the device confirmed the report.The supplier provided the following, "root cause was not determined.A review of the device history record did not reveal any anomalies.An examination of the device confirmed the complaint of 'sheath detached from the handle'.Additionally, it was discovered that the red cap was missing from the device." 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.

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• 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: 18721530
• MDR Text Key: 336318243
• Report Number: 1037905-2024-00090
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASM-1-S
• Device Lot Number: W4773881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2023
• 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: UNKNOWN ENDOSCOPE MAKE AND MODEL.