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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp (omsc) for evaluation.Since the lot no.Is unknown, the manufacturing history record (dhr) could not be reviewed.However, omsc has only shipped devices which passed the inspection.There was no malfunction report of the subject device concerning the events.The exact cause of the reported event could not be conclusively determined because the subject device was not returned omsc for evaluation.

Event Description

On february 13th, 2020, olympus medical systems corp.(omsc) received a literature titled ¿impact of electrical pulse cut mode during endoscopic papillectomy:pilot randomized clinical trial¿.The literature reported results of the sixty procedures of endoscopic papillectomy using an olympus disposable electrosurgical snare between april 2016 and april 2018.Nine cases of procedure-related delayed bleeding were reportedly observed.The delayed bleedings were stopped using a non-olympus hemoclip (resolution, boston scientific (b)(4)).The relationship between the subject device and all of the reported complications could not been determined based on the available information.According to the number of the complications and the number of olympus device which mighty have contributed to the complications, omsc is submitting nine medical device reports.This is five of nine reports.

• 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 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9821865
• MDR Text Key: 194346608
• Report Number: 8010047-2020-01758
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention