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

Model Number G22633

Device Problem Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2020

Event Type  malfunction  

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 customer attached two pictures in an email, the pictures are of three different snares.Two of the snares are asmh-1.The third snare is sasm-1-s, but it is not possible to confirm if it is the same device.There are severe kinks on the catheters at the distal end of the handles for all three snares.These pictures are inconclusive for retraction difficulties.Our laboratory evaluation of the product said to be involved could not confirm the retraction difficulties, but the damage to the catheter could have prevented retraction during use.The device was returned fully retracted into the sheath.During a functional test the snare was advanced and retracted without any issues.There were various kinks and bends in the sheath from the distal end of the handle 11 cm to 15.5 cm.These kinks match the customer's description of "coiling by the handle".These kinks can be due to excessive force applied when retracting the snare head.There were other slight bends throughout the length of the device.The device was evaluated inside an olympus jf type 130 side viewing scope, the scope was placed in a retroflexed position.The snare advanced and retracted without any resistance or issues.No other anomalies were found.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 user indicated the device was used to retrieve "writing pen objects".This device is not intended to be used for removal of "writing pen objects " or any other device.This is the most likely cause of the reported difficulties and damage to the catheter.The intended use in the instructions for use (ifu) states: "this device is used with an electrosurgical unit for endoscopic polypectomy." the instructions for use also states: "do not use this device for any purpose other than the stated intended use." prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection.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.Additional comments regarding this report: based on the information provided that the device was used off-label, a cook representative will be directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an esophagogastroduodenoscopy (egd), the physician used an acusnare polypectomy snare soft (sasm-1-s) on a patient of unknown age and gender on (b)(6) 2020.The device was coiling by the handle so [the user] was unable to get a tight squeeze when [the user] retrieved writing pen objects for egd.Two snares [ acusnare polypectomy snare soft (sasm-1-s) and acusnare polypectomy snare (asmh-1)] were attempted with the same outcome and to finish the procedure the physician used a rothnet snare with no further complications.The following was received on 24-jun-2020: because they were using them off-label by retrieving foreign bodies, as they would tighten down on object to grasp and retrieve it, the snare would tighten down on the object but they could not get good purchase [grip] so they would tighten more and as they continued to close down the snare wire on the object so as not to lose it, they could draw back on the handle but the snare wouldn¿t tighten because the sheath material was buckling just distal 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 the complaint states that two cook devices were used; the acusnare polypectomy snare soft (sasm-1-s) and acusnare polypectomy snare (asmh-1).This mdr is being sent to capture this occurrence where the cook acusnare polypectomy snare soft (sasm-1-s) device kinked during use causing retraction difficulty.An mdr for the other cook device will be submitted separately.

• 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: 10215689
• MDR Text Key: 233948192
• Report Number: 1037905-2020-00257
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002226333
• UDI-Public: (01)00827002226333(17)220919(10)W4263335
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2022
• Device Model Number: G22633
• Device Catalogue Number: SASM-1-S
• Device Lot Number: W4263335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2019
• 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