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

Model Number	KD-630L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there was no description of the device's malfunction.
Event or Problem Description
On june 29, 2020, olympus medical systems corp.(omsc) received literature titled "original article safety of endoscopic submucosal dissection for gastrointestinal neoplasms:risk of thrombosis".In the literature, it was reported that perforation was observed in 14 patients with the endoscopic submucosal dissection (esd).We do not found that what the severity of these perforations is and also whether these perforations could be completely closed or not.The esd procedure was performed using the single use electrosurgical knife (a flex-knife, and an insulation-tipped diathermy knife).The model number was not identified.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.However, the literature indicated that the perforation associated with esd.Therefore, omsc will submit 14 medical device reports (mdr) for each incomplete closure event.This report is 10 of 14 reports for the intraoperative perforation of the single use electrosurgical knife.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10299700
• Report Number: 8010047-2020-04642
• Device Sequence Number: 2603441
• Product Code: KNS
• UDI-Device Identifier: 04953170208416
• UDI-Public: 04953170208416
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: KD-630L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other