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 Type  malfunction  

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: 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 snare softs are subjected to a visual inspection and functional test 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 rare.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 not opened and tested prior to usage.The snare was introduced down biopsy channel of colonoscope, then it was opened to perform polypectomy.The wire of snare [snare head] observed to be faulty as it appeared damaged and "frayed." the device was removed from the colonoscope prior to being used for polypectomy.The damage is visible on inspection, especially to the very tip or distal end of snare.Per the sales rep, "the defect is quite obvious upon looking at the snare.The ¿fraying¿ was in the very tip of the snare (at the top), and the wires appeared to be sharp." 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.

Event Description

During a colonic polypectomy, the physician used a cook acusnare polypectomy snare soft.The snare was not opened and tested prior to usage.The snare was introduced down biopsy channel of colonoscope, then it was opened to perform polypectomy.The wire of snare [snare head] observed to be faulty as it appeared damaged and "frayed." the device was removed from the colonoscope prior to being used for polypectomy.The damage is visible on inspection, especially to the very tip or distal end of snare.Per the sales rep, "the defect is quite obvious upon looking at the snare.The ¿fraying¿ was in the very tip of the snare (at the top), and the wires appeared to be sharp." 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: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with a yellowish substance on the snare wire.There were no kinks or bends noted throughout the catheter of the device.During a visual examination, it was noted that the distal tip of the snare head was frayed.One of the strands of the braided cable was protruding at the tip of the snare.The braided wires were possibly what was seen by the customer under the endoscopic visualization.It is unknown when or how the wires became frayed.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 cause of the users report is a filament of the snare wire that has broken on one end of the snare head and unraveled.A definitive cause for this broken filament of wire could not be determined.Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection and functional test 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 rare.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.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with a yellowish substance on the snare wire.There were no kinks or bends noted throughout the catheter of the device.During a visual examination, the distal tip of the snare head was frayed.One of the strands of the braided cable is protruding at the tip of the snare.The braided wires are possibly what was seen by the customer under the endoscopic visualization.It is unknown when or how the wires became frayed.The device was sent to the supplier for further evaluation.The supplier provided the following: "the device was visually evaluated.No defects to the handle or catheter were noted.However, frayed wires were detected upon deploying the snare head.The reported event for "frayed" wires was confirmed.The device was functionally evaluated.During testing, with the device coiled in three (3) loops, it was confirmed that the device operated properly when the handle was manipulated.The device opened and closed as designed.The assignable cause for the frayed wires is unknown.The device history records were reviewed.The assembly order for this lot were manufactured in may and june 2018 respectively.Relevant defects were not noted in the manufacturing and/or final quality control 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 reported issue from the user that the "wires appear to be frayed" was confirmed.The assignable cause for the frayed wires is unknown.The devices receive a 100% inspection prior to release and shipment.Although the supplier evaluation was unable to assign a root cause, the frayed wires most likely occurred due to a processing issue at the supplier.Further clarification from the supplier found that the broken snare wire braid unraveled to the crimp and most likely indicates that the braided wire was not in the crimped cannula during manufacturing of the device.Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection and functional test 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 rare.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 not opened and tested prior to usage.The snare was introduced down biopsy channel of colonoscope, then it was opened to perform polypectomy.The wire of snare [snare head] observed to be faulty as it appeared damaged and "frayed." the device was removed from the colonoscope prior to being used for polypectomy.The damage is visible on inspection, especially to the very tip or distal end of snare.Per the sales rep, "the defect is quite obvious upon looking at the snare.The ¿fraying¿ was in the very tip of the snare (at the top), and the wires appeared to be sharp." 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
• MDR Report Key: 7967299
• MDR Text Key: 126090841
• Report Number: 1037905-2018-00482
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002227033
• UDI-Public: (01)00827002227033(17)210620(10)W4083705
• Combination Product (y/n): N
• PMA/PMN Number: K851958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2018

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 Expiration Date: 06/20/2021
• Device Model Number: G22703
• Device Catalogue Number: SASMH-1-S
• Device Lot Number: W4083705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 09/20/2018; 11/29/2018
• Supplement Dates FDA Received: 11/29/2018; 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COLONOSCOPE, UNKNOWN MAKE OR MODEL.