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

Catalog Number SAS-1-S

Device Problems Nonstandard Device (1420); Material Separation (1562)

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

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

Section g: pma/510(k): k173673.Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photos describing the event.The first photo shows the labeling on the pouch and it matches that in the report.The second photo shows the handle portion of the device and the snare head advanced.There is a significant portion of the drive wire exposed at the distal end and the drive wire is no longer connected to the handle.The third photo shows the pouch with the device coiled inside, as well as the cpn/vendor lot information.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 evaluation of the photos provided confirmed the report.However, 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.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.

Event Description

During an intestinal polyp removal, the physician used a cook acusnare polypectomy snare soft.It was reported [that] during endoscope inspection, user detected there is [a] polyp in intestine, and then took cook snare to remove the polyp but found out the snare wire broken while pulling the handle.User retracted the device from patient and changed to another same device to complete the procedure.A picture provided by user of snare handle and loop show that the drive wire is no longer connected to the handle.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

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.The first photo shows the labeling on the pouch and it matches that in the report.The second photo shows the handle portion of the device and the snare head advanced.There is a significant portion of the drive wire exposed at the distal end and the drive wire is no longer connected to the handle.The third photo shows the pouch with the device coiled inside, as well as the cpn/vendor lot information.Our laboratory evaluation of the product said to be involved confirmed the report.The snare was returned fully advanced with part of the drive wire extending out of the sheath.During visual examination, it was seen that the drive wire had separated from the handle cannula inside the handle.When the handle was actuated, the snare would not advance or retract.The device was returned to the supplier for further evaluation and the following was provided, "visual evaluation of the device confirms the disassembly of the device based on the client complaint.All components were returned in the complaint packaging.The pushrod was noticed to not have an extensive crimp, which goes against the work instructions.The snap pin was visually acceptable, the pushrod was not bent, drivewire was not frayed or shortened, tubing was not shortened or kinked, and the snare was properly formed and crimped to the drivewire.Functional evaluation of the device was limited in the configuration upon reception.The components of the device were placed back into functional locations and were tested to monitor functionality.It was noticed that the drivewire of the device was not properly being held in place by the crimp of the pushrod.Once the handle was actuated forward and retracted back the drivewire was flushed out of the pushrod and no connection was present to allow full retraction for repeatability.Functionality was lost after detachment of the drivewire from the pushrod.The reported complaint for the device is confirmed based on visual and functional evaluation of the device.Root cause of the non-conformance is due to an insufficient crimp between the drivewire, pushrod, and snap pin subassembly." the device history record for (pt) 489130 (720) was reviewed.(pt) 489130 (720) was manufactured august 2023.There were no relevant defects noted in the manufacturing/fqc checklists.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 evaluation of the photos and returned device confirmed the report.The supplier provided the following, "the cause of the insufficient crimp was determined to be human error.Operators will be advised of the complaint.A review of the device history record did not reveal any anomalies.The visual and functional valuation of the device confirmed the customer's complaint.An inadequate crimp between the drivewire, pushrod, and snap pin subassembly was determined to be the reason the drivewire separated from the handle." 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 and this represents an isolated occurrence.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 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: 18777139
• MDR Text Key: 336208259
• Report Number: 1037905-2024-00105
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAS-1-S
• Device Lot Number: W4774624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2023
• 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.