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.

• 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 (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 12385916
• MDR Text Key: 268792675
• Report Number: 1037905-2021-00457
• Device Sequence Number: 1
• Product Code: KNS
• 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

• 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

• Device Model Number: G22630
• Device Catalogue Number: ASJ-1-S
• Device Lot Number: W4319003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/30/2021 Patient Sequence Number: 1

Treatment

COVIDIEN ELECTROSURGICAL GENERATOR; OLYMPUS HQ190 ENDOSCOPE