MAUDE Adverse Event Report: COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE SOFT; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number G22703

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter; occupation: other-healthcare professional: coordinator.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 device was returned with a dried brown substance inside the tubing near the distal end.The device functioned properly when handle was manipulated to advance/retract the snare.When the snare was advanced it was noted that the distal end of the hex was frayed.Under magnification it could be seen that the snare was unraveled on the tip, the unraveled wire had an exposed sharp end.The snare would retract, however there was friction when retracting.The resistance/friction felt during retraction appears to be caused by the sharp edge from the frayed wire.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.The device was returned to the supplier.The supplier provided the following: visual evaluation: the device was visually evaluated.No defects to the handle or sheath were noted.The distal end of the snare head was determined to be frayed.The reported event for "frayed tip" was confirmed.Functional evaluation: the device was functionally evaluated.During testing, with the device held in straight, u-shaped, and three 8" loop coiled positions, respectively, it was confirmed that the device operated properly when the handle was manipulated.The device opened and closed and designed.Minimal resistance (friction) was detected upon manipulating the handle to deploy the snare head.The resistance (friction) was based on the frayed wires within the id of the sheath.Upon exit of the frayed wires, no additional resistance was noted.The device history records for process work order (pwo) manufactured august 2020 were reviewed.There were no relevant defects noted in the manufacturing and/or fqc checklist records.Investigation conclusion: the supplier confirmed the complaint.The complaint was confirmed but the cause of the frayed tip is unknown and therefore, no corrective action has been assigned.All devices receive a 100% inspection prior to release and shipment.Prior to distribution, all acusnare polypectomy snare soft are subjected to a visual inspection and functional test to ensure proper workability.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 a colonic polypectomy, the physician used a cook acusnare polypectomy snare soft.The snare was advanced to the end of the scope, olympus pcf-h180, and when snare was opened it was noted the distal end was fraying.The snare was removed and another of the same device was used to complete the procedure.There was no reportable information at this time.Our evaluation of the returned device on 12/31/2020 determined that the snare head was frayed/unraveled.During retraction there was some friction noted when the frayed portion of the snare entered the catheter and was sharp [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.

• Brand Name: ACUSNARE POLYPECTOMY SNARE SOFT
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): 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: 11245904
• MDR Text Key: 257674705
• Report Number: 1037905-2021-00036
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002227033
• UDI-Public: (01)00827002227033(17)230825(10)W4379046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2023
• Device Model Number: G22703
• Device Catalogue Number: SASMH-1-S
• Device Lot Number: W4379046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2020
• 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