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

Catalog Number ASDB-25-015-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemostasis (1895); Pain (1994)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant products: electrosurgical generator - unknown make and model.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 includes the following to ensure proper use of the device: "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." "advance device, in small increments, until endoscopically viewed exiting endoscope." "advance snare wire out of sheath and position it around polyp to be removed.Warning: when applying current, tissue must be isolated from surrounding mucosa.Failure to isolate tissue may cause fulguration of normal mucosa and/or perforation.Contact of snare wire with endoscope during electrosurgery may cause grounding, which could result in injury to patient and/or operator as well as damage to endoscope and/or snare wire." difficulty with movement of the snare (i.E.Snare advancement or retraction difficulty) can occur if the outer catheter and/or drive cable becomes kinked during use or general handling, perhaps due to an application of excessive pressure or improper insertion method.Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection and functional testing to ensure device integrity.A review of the two related device history records confirmed that both lots 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

The following was received from medwatch (b)(4)."during a colonoscopy a polypectomy was performed with a cook acusnare polypectomy [duck bill] snare.The snare sprung off the polyp site, touched the opposing wall, leaving a small superficial mark.The polypectomy site began to bleed.Three (3) endoscopic clips were required to achieve hemostasis.The patient had significant abdominal pain after the procedure and was transferred to the hospital for further evaluation.The patient was admitted to the hospital with colorectal surgery and gastroenterology consults done and was treated with conservative management at this time." additional information was received 10/30/2017: the duck bill snare was described to me as an instrument that snips the polyp and cauterizes that area all at once.The physician reported that the tip appeared bent and charred upon removal from the patient.The patient needed a consult only, no surgery was required.Bowel rest, pain medicine, intravenous fluids, observation, abdominal ct (computerized tomography) scan, and antibiotics were required for conservative management.The patient complained of pain in the area of the staples [clips].The concern was for perforation.The patient was sent from the ambulatory center to the university emergency department for a ct scan and colorectal surgery consult.

• 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
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7040785
• MDR Text Key: 92325243
• Report Number: 1037905-2017-00693
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002226494
• UDI-Public: (01)00827002226494(17)200620(10)W3881402
• 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,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2017,11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Device Operator: Health Professional
• Device Catalogue Number: ASDB-25-015-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2017
• Distributor Facility Aware Date: 09/26/2017
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2017
• Date Manufacturer Received: 10/23/2017
• Date Device Manufactured: 06/20/2017
• 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
• Treatment: OLYMPUS PCF-0180AL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR