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

Catalog Number	ASJ-1-S
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: conmed aspen excaliber electrosurgical generator investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A visual inspection of the returned product was performed and it was noticed that the sheath below the handle was crinkled.The sheath was bunched up from the base of the handle to 10.5 cm from the base of the handle.The handle of the device was manipulated and the snare head advanced outside the sheath as intended.The handle of the snare was manipulated in order to retract the snare head back into the sheath, however while retracting the snare head, the sheath began to bunch up near the handle.Due to the sheath bunching up near the handle of the device, retraction difficulty was encountered and the snare head would not retract fully back in to the sheath without straightening out the bunched area near the handle.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.Due to the retraction difficulty and kinking near the base of the handle, no further functional tests were performed.A visual inspection of the snare head under magnification was performed and the tip of the snare head appears to show some charring.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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use contains 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 placement and utilization of patient return electrode.Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure." "inspect active cord.Cord must be free of kinks, bends, breaks and exposed wires to allow for accurate transfer of current.If an abnormality is noted, do not use active cord." "with electrosurgical unit off, prepare equipment.Securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit.Following instructions from electrosurgical unit manufacturer, position patient return electrode and connect it to electrosurgical unit." "fully retract and extend snare to confirm smooth operation of device.Note: if using an acusnare, slide adjustable marker, located in handle, to establish a reference point indicating full retraction of snare into sheath and to set up reference points for establishing thickness of tissue being excised." "following electrosurgical unit manufacturer's instructions for settings, verify desired settings and activate electrosurgical unit.Note: 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 or Problem Description
During a colonoscopy, the physician used a cook acusnare polypectomy snare.The registered nurse (rn) from the facility called in the complaint detailing that the complaint [device] was being used to attempt removal of a very large dense polyp found at the cecum.The snare was connected to cautery, inserted, and placed around the polyp.The snare would not fully cut the polyp.After the third attempt to cut through the polyp, it was decided to remove the snare from the patient; however, the snare would not release from the polyp.A gastroenterologist was called and he was eventually able to cut a portion of the polyp and remove the snare from the patient.The nurse noted the snare had a lot of twisting and crinkling about 6-8 inches down the shaft.The reporter confirmed the device was not turned or twisted during the procedure.The user concluded removal of this polyp, pulled a different snare and continued with removal of other polyps.The polyp which encountered the snare issue was left as the patient is returning for a hemicolectomy unrelated to this complaint event.There were not adverse effects noted, but the patient was under prolonged anesthesia.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
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7995853
• Report Number: 1037905-2018-00495
• Device Sequence Number: 1190724
• Product Code: KNS
• UDI-Device Identifier: 00827002226302
• UDI-Public: (01)00827002226302(17)201114(10)W3996405
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K851958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2020
• Device Catalogue Number: ASJ-1-S
• Device Lot Number: W3996405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR