MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE ELECTROSURGICAL SNARE

Model Number SD-230U-20

Device Problem Unintended Movement (3026)

Patient Problem Perforation (2001)

Event Date 03/14/2019

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report has not yet been returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During a polypectomy, the subject device was used.The device did not work.The patient perforated.The patient is recovering.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Tthere was no irregularity with the deivce.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes that the perforation occurred due to an excessive amount of conduction.The above device handling has warned in the instruction manual as follows.-when applying the current, do not use an excessive amount of conduction.Doing so could cause patient injury such as perforations and/or bleeding.When necessary, provide treatments to prevent perforations or bleeding from occurring after the procedure.Ensure that postoperative follow-ups are performed, and confirm that no abnormalities are found in the patient.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Type of Device: DISPOSABLE ELECTROSURGICAL SNARE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8472043
• MDR Text Key: 140588802
• Report Number: 8010047-2019-01459
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• PMA/PMN Number: K955650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-230U-20
• Device Lot Number: 78V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other