MAUDE Adverse Event Report: COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE; FDI, SNARE, FLEXIBLE

Model Number G22647

Device Problem Failure to Conduct (1114)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k191048.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.The instructions for use contain the following information to assist with proper set-up and use of the device: "before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper selection, placement and utilization of the patient return electrode.Ensure that a proper path from the patient return electrode to the electrosurgical unit is maintained throughout the procedure." "inspect the active cord.The cord must be free of kinks, bends, breaks and exposed wires to allow for the accurate transfer of current.If an abnormality is noted, do not use active cord." "with the electrosurgical unit off, prepare the equipment.Securely connect the active cord to the device handle and electrosurgical unit.The active cord fittings should fit snugly into both the device handle and the electrosurgical unit.Following the instructions from the electrosurgical unit manufacturer, position the patient return electrode and connect it to the electrosurgical unit." "following the electrosurgical unit manufacturer's instructions for settings, verify the desired settings and activate the electrosurgical unit.Note: the maximum rated input voltage for this device is 2kvp-p for cut mode and 5 kvp-p for coagulation mode." 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.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 polypectomy, the physician used two (2) cook acusnare polypectomy snares.The snares would not open and close correctly.Once they got them open, they would not cut through the polyp.The procedure was successfully completed with a competitive snare.Additional information provided indicates that the device did not allow any transfer of electrical power.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: a product evaluation was not performed in response to this report because the products said to be involved was not provided to cook for evaluation.The report could not be confirmed.However, two (2) sealed devices from the lot number provided were returned.Sealed device 1: our evaluation of the sealed device returned could not confirm the report as it was described.The handle of the device was manipulated, and the snare head would open and close with no resistance felt.During a visual inspection of the device, there was no damage noted on the device.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.An additional functional test was performed by attaching the active cord to the electrical pin.The active cord connected easily and remained securely connected to the device.The device was connected to a valley lab generator and power was applied.The snare cut simulated tissue as expected.Sealed device 2: our evaluation of the sealed device returned confirmed the report.The handle of the device was manipulated, and the snare head would open and close with no resistance felt.During a visual inspection of the device, there was no damage noted on the device.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.An additional functional test was performed by attaching the active cord to the electrical pin.The active cord connected easily and remained securely connected to the device.The device was connected to a valley lab generator and power was applied.The snare cut through the simulated tissue with a lot of resistance.The snare had no issues with conducting current to coagulate and cut.However, the device began to experience retraction issues during the cutting of the tissue.When the snare was being retracted, the cannula on the distal end began to catch on the catheter and would not allow it to close.This caused some damage on the catheter near the handle.The distal end was cleaned off and observed under magnification, the solder joint on the tip of the snare head was not buffed appropriately, and the solder looks uneven around the cannula.A lab meeting was held with manufacturing.During the lab meeting, sealed device two (2) was function tested and noted that the snare would catch on the distal end of the catheter when retracting the snare.The snare solder was catching causing retraction difficulty.It was discussed that the solder on the snare had not been buffed down appropriately and should have been caught during inspection of workability.There are two cannulas on the distal end which form the duck bill head.The nonconforming cannula is closest to the tip of the snare.There are solder balls on both sides of the cannula holding the wire in place.These solder balls are buffed down to allow for smooth retraction and extension of the snare head.The edges around the cannula should be tapered down and smooth.This process is done by manufacturing after the soldering process is complete.The distal end is inspected during quality check (qc) to ensure workability of the device.The user's report indicated "they would not cut through the polyp" and "the device did not allow any transfer of electrical power".Our evaluation of the returned sealed devices confirmed difficulty with retraction (sealed device 2).This could be representative of the user's report of unable to cut through the polyp, since difficulty with retraction may present as unable to cut through the polyp.We were not able to recreate the report of "did not allow any transfer of electrical power".It is unknown if the used devices presented with the same manufacturing defect associated with the buffing process since they were not returned.However, since one of the sealed devices was manufactured correctly, we can conclude that at least a portion of the lot was conforming.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: used devices: we could not conduct a complete investigation because the products said to be involved were not returned for evaluation.A definitive cause for the reported observation could not be determined.Sealed device 1: a definitive cause for the reported observation could not be determined because sealed device 1 functioned as intended.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Sealed device 2: the solder joint on the distal end has not been buffed adequately.The solder joint would therefore catch on the catheter and the snare would not retract as intended.The report is confirmed for this device.A notification of operator related complaint form was provided to production management to make them aware of an operator related complaint.A record of notification was also sent to production personnel.The instructions for use contain the following information to assist with proper set-up and use of the device: "before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper selection, placement and utilization of the patient return electrode.Ensure that a proper path from the patient return electrode to the electrosurgical unit is maintained throughout the procedure." "inspect the active cord.The cord must be free of kinks, bends, breaks and exposed wires to allow for the accurate transfer of current.If an abnormality is noted, do not use active cord." "with the electrosurgical unit off, prepare the equipment.Securely connect the active cord to the device handle and electrosurgical unit.The active cord fittings should fit snugly into both the device handle and the electrosurgical unit.Following the instructions from the electrosurgical unit manufacturer, position the patient return electrode and connect it to the electrosurgical unit." "following the electrosurgical unit manufacturer's instructions for settings, verify the desired settings and activate the electrosurgical unit.Note: the maximum rated input voltage for this device is 2kvp-p for cut mode and 5 kvp-p for coagulation mode." 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.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.

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• Type of Device: FDI, SNARE, FLEXIBLE
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11020137
• MDR Text Key: 251613194
• Report Number: 1037905-2020-00557
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00827002226470
• UDI-Public: (01)00827002226470(17)230423(10)W4343222
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2023
• Device Model Number: G22647
• Device Catalogue Number: ASDB-15-015-S
• Device Lot Number: W4343222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOGATOR ELECTROSURGICAL GENERATOR.; OLYMPUS CF190 COLONOSCOPE.