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

Model Number G22630

Device Problem Failure to Cut (2587)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

This investigation is ongoing and a follow up emdr will be sent upon completion.

Event Description

During a polypectomy, the physician used two (2) acusnare polypectomy snares.They closed the first snare onto the polyp.They tried to cut with cautery but the cautery would not cut the polyp.Then, the snare would not open for removal.The snare was stuck on the polyp.They tried to use a second snare to cut the polyp and free the first snare, but it had the same problem with both cautery and not reopening and became stuck as well.The patient was sent to surgery for a right hemicolectomy in order to remove the snares and the polyp.A section of the device did not remain inside the patient's body.The patient was sent to surgery for a right hemicolectomy in order to remove the snares and the polyp due to this occurrence.

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.The instructions for use contains the following information to assist with proper set-up and use of the device: "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." the instructions for use states the following system preparation warnings: "with electrosurgical unit off, prepare the equipment.Securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit." the instructions for use also states the following potential complications: ¿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 the patient return electrode to electrosurgical unit is maintained throughout the procedure." system preparation warnings: "fully retract and extend snare to confirm smooth operation of device.¿ the instructions for use, warning section also states: ¿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.¿ the instructions for use states these potential complications: ¿do not use this device with an output higher than the rated voltage 2.0 kvp-p (1000 vp) for cut mode and 5kvp-p (2500 vp) for coagulation mode.¿ the instructions for use further states: ¿do not use this device with an active cord which has a maximum voltage rating less than 5kvp-p (2500 vp).This could cause thermal injury to the patient, operator or assistant.¿ 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) acusnare polypectomy snares.They closed the first snare onto the polyp.They tried to cut with cautery but the cautery would not cut the polyp.Then, the snare would not open for removal.The snare was stuck on the polyp.They tried to use a second snare to cut the polyp and free the first snare, but it had the same problem with both cautery and not reopening and became stuck as well.The patient was sent to surgery for a right hemicolectomy in order to remove the snares and the polyp.The following was received on 09/03/2021- the intention of the original procedure to remove a large colon polyp.Surgery was an unexpected complication due to the malfunction.A section of the device did not remain inside the patient's body.The patient was sent to surgery for a right hemicolectomy in order to remove the snares and the polyp due to this occurrence.

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• 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: 12385916
• MDR Text Key: 268792675
• Report Number: 1037905-2021-00457
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002226302
• UDI-Public: (01)00827002226302(17)230211(10)W4319003
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Device Model Number: G22630
• Device Catalogue Number: ASJ-1-S
• Device Lot Number: W4319003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COVIDIEN ELECTROSURGICAL GENERATOR; OLYMPUS HQ190 ENDOSCOPE; COVIDIEN ELECTROSURGICAL GENERATOR; OLYMPUS HQ190 ENDOSCOPE
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR