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

Model Number G22631

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

Initial evaluation: our laboratory evaluation of the product said to be involved confirmed the report that the snare head had detached from the distal end.The detached snare head was returned with the rest of the device.When the handle was manipulated, the drive wire advanced and retracted without any resistance.During a visual inspection of the drive wire and detached snare head, the distal end of the drive wire did not exhibit any evidence of a crimp and was cut at an angle.The proximal end of the crimped cannula of the detached snare head appeared to not be fully crimped.The device was sent back to the supplier for further evaluation.The supplier provided the following: "one" device from the reported event was returned inside of a zip type bag with proof of decontamination.The supplier evaluation of the device determined the following.Visual evaluation: the device was visually evaluated.No defects to the handle or catheter were noted.The snare head was severed from the distal end of the assembly.Additionally, the distal end of the drive wire did not exhibit any evidence of a crimp.Lastly, the proximal end of the crimped cannula was not adequately crimped when compared to a similar device.The reported event for "snare head fell off catheter" was confirmed.Functional evaluation: the device was functionally evaluated.During testing, with the device held in straight, u­ shaped, and three (3) coiled positions, respectively, it was confirmed that the device operated properly when the handle was manipulated.The drive wire advanced and retracted smoothly and freely.The deployment of the snare head could not be evaluated.Root cause: assembly error.The device history records were reviewed.The device was manufactured in january 2019.The manufacturing records and/or fqc checklist did not indicate relevant defects." 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.A review of the test summary sheet was performed.It was verified that the devices for the lot number involved met the acceptable criteria.Investigation conclusion: the supplier provided the following: the reported issue from the user 'snare head fell off' was confirmed.The proximal end of the cannula was not adequately crimped.The assignable cause was due to an assembly error.All operators involved in the assembly will be re-trained on the appropriate procedure.Prior to distribution, all acusnare polypectomy snares 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

Prior to an endoscopic procedure, the physician chose a cook acusnare polypectomy snare.The nurse checked the snare before use and the snare fell off the end of the catheter.They opened another of the same snare which was fine.This happened prior to being inserted down the endoscope.The snare was unused but may be contaminated by gloved hands.This occurred prior to patient contact; there was no impact to the patient.

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• 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: 8971792
• MDR Text Key: 157521676
• Report Number: 1037905-2019-00526
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002226319
• UDI-Public: (01)00827002226319(17)220201(10)W4174683
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K851958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: G22631
• Device Catalogue Number: ASM-1-S
• Device Lot Number: W4174683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2019
• 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