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

Model Number G22632

Device Problems Fracture (1260); Retraction Problem (1536); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.The investigation is currently in progress.A follow-up report will be sent following the completion of the investigation.

Event Description

During an endoscopic procedure to remove an intestinal polyp, the physician used an acusnare polypectomy snare soft.The user advanced the device to the desired position and tried to remove the polyp and found out that the wire at the handle was broken.The user retracted the device [from the endoscope] and changed to another one of the same devices to complete the procedure.Due to the handle cannula breaking and the snare head being advanced, it was reasonable to conclude the device would not retract [subject of report].Additional information was provided on 24-september-2020 which confirmed the inability or difficulty to retract the snare once advanced out of the sheath.The user pulled the handle with no response from snare.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 user provided four photos, the photos show the drive wire separated from the handle spool of the device.The snare head is in the open position, which matches how the product was returned.The user also included a picture of the front of the pouch which matches the lot number in the report.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the snare head fully extended and the drive wire has disconnected from the handle.During a visual inspection of the drive wire, the proximal end has an indentation indicating the drive wire had been torqued.A function test was not possible, due to the condition of the device.When the drive wire was manipulated manually with pliers, the snare head would advance and retract.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 sent back to the supplier.The supplier provided the following: visual evaluation: no physical defects to the handle, sheath, or snare head were noted.However, the drive was physically detached from the electrical conductivity pin within the handle spool.Upon further examination, the drive wire was verified to be crimped properly.Lastly, the electrical conductivity pin was evaluated and found to be loose.Functional evaluation: the usual functional evaluation could not be performed due to the condition of the device.However, pliers were used to simulate actuation of the handle.When the drive wire was manipulated forward and backward, the snare head extended and retracted as designed.The device history records for process work order (pwo) manufactured 09/2019 was reviewed.Process traveler (pt) manufactured 09/2019 was reviewed.Process traveler (pt) manufactured 09/2019 was reviewed.There were no relevant defects noted in the manufacturing and/or final quality check (fqc) checklist records.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: the supplier provided the following: the evaluation confirmed the complaint.The assignable cause was not determined.The electrical pin was determined to be loose.Each device in the lot received a 100% inspection prior to release and shipment to include: (qly-010w) step 16 ensure drive cable is completely inserted in handle cannula.Step 17 manual tug to check security of snare and drive cable to snare.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 unusual 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: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10649546
• MDR Text Key: 227952638
• Report Number: 1037905-2020-00428
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002226326
• UDI-Public: (01)00827002226326(17)221002(10)W4268384
• Combination Product (y/n): N
• PMA/PMN Number: K851958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2022
• Device Model Number: G22632
• Device Catalogue Number: SAS-1-S
• Device Lot Number: W4268384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 10/06/2020
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE, UNKNOWN MODEL OR MANUFACTURER