MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE

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 following inspections.Length of the cutting knife.No bent on the cutting knife.Operation of the cutting knife.There was no malfunction report of the subject device concerning the events.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

Event Description

On january 15th, 2020, olympus medical systems corp.(omsc) received a literature titled ¿the utility of a novel colonoscope with retroflexion for colorectal endoscopic submucosal dissection¿.The literature reported results of two hundred and twenty-seven procedures of endoscopic submucosal dissection (esd) to resect colorectal lesions located in the left-side colon between april 2009 and february 2018.Some or all of the esd procedures have been performed with unspecified olympus single use electrosurgical knife (dual knife), single use electrosurgical knife (dual knife j), and/or single use electrosurgical knife (it knife nano).Seven cases of postoperative bleedings and eight cases of intraoperative perforation were reportedly observed.The relationship between the subject devices 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 devices which mighty have contributed to the complications, omsc is submitting forty-five medical device reports.This is a report on five of seven cases of postoperative bleeding regarding dual knife j and twenty of forty-five reports.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 9669144
• MDR Text Key: 189702084
• Report Number: 8010047-2020-01117
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• 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: 01/15/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other