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

Model Number G22704

Device Problem Failure to Conduct (1114)

Patient Problems Hemorrhage/Bleeding (1888); Hemostasis (1895)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

Continued from concomitant medical product: electrosurgical generator, unknown make or model.Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The returned device was advanced through an ec-3830 tl pentax colonoscope (2.8 mm channel).The endoscope was placed in a curved position to demonstrate a worst case scenario.Once the device was successfully through the distal end of the endoscope, the handle was actuated to test for advancing and retracting of the snare.The snare opened and closed as intended.Resistance was not encountered when opening and closing the snare.During a visual inspection under magnification, the snare head did not exhibit any charred areas.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.A further evaluation was performed by attaching the active cord to the device handle and electrosurgical unit.The active cord connected easily to the device handle and remained securely connected during the evaluation.The device was connected to an erbe icc 200 generator and power was applied.The snare cut the simulated tissue as expected.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." "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.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 colonoscopy, the physician used a cook acusnare polypectomy snare soft.The snare did not ignite for cautery.The snare was cold.The following additional information was received (b)(6) 2018 from the cook area representative: my understanding is that it was supposed to be hot snare and it did not get hot.Second, i think they used a couple clips after the polyp was removed cold and not biopsy forceps.But, you can confirm with the facility if different.This is just my understanding or what i think what happened.The following was received from the reporter at the user facility on 01/25/18: the physician used forceps to stop the bleeding.I am not familiar with the procedure.However, by the way the physician described the event, yes, the physician attempted the procedure with the snare as a hot biopsy.The following additional information was provided from the area representative on (b)(6) 2018: i think what they mean is the snare was used cold to remove tissue because cautery did not work.Clarification was received from the area representative on (b)(6) 2018 indicating that the facility would not have pre-tested the device outside the patient and would have noticed [no electrosurgical current present at the snare head] while cutting inside the patient, during the polypectomy.

• 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 Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7249497
• MDR Text Key: 99301474
• Report Number: 1037905-2018-00042
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002227040
• UDI-Public: (01)00827002227040(17)201205(10)W4003647
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: G22704
• Device Catalogue Number: SASMM-1-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2018
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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
• Patient Outcome(s): Required Intervention