MAUDE Adverse Event Report: COOK INCORPORATED ACUSNARE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number G22633

Device Problem Sharp Edges (4013)

Patient Problem No Information (3190)

Event Date 12/05/2018

Event Type  malfunction  

Event Description

Snare had defective edge sharp and witnessed during procedure.

• Brand Name: ACUSNARE
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8304532
• MDR Text Key: 135004734
• Report Number: 8304532
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2019

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
• Device Operator: Health Professional
• Device Model Number: G22633
• Device Catalogue Number: SASM-1-S
• Device Lot Number: 210815 W4108069
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1