MAUDE Adverse Event Report: OLYMPUS AMERICA, INC DISPOSABLE ELECTROSURGICAL SNARE

Model Number SD-210U-10

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Failure to Cut (2587)

Patient Problem Laceration(s) (1946)

Event Date 10/13/2022

Event Type  Injury  

Event Description

A user facility reported to olympus that while using the disposable electrosurgical snare, after snaring a large polyp, the physician could not cut or retract the snare.The snare and polyp both had to be surgically removed from the patient; the patient was taken to surgery immediately.Additional information has been requested; despite multiple attempts, none has been received.If received, a supplemental report will be sent.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Type of Device: DISPOSABLE ELECTROSURGICAL SNARE
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 16158107
• MDR Text Key: 307291827
• Report Number: 2429304-2023-00006
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170298417
• UDI-Public: 04953170298417
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2022,01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD-210U-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention