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

Model Number	KD-1L-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
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 serial 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 is no description of the device's malfunction.
Event or Problem Description
On november 2, 2020, olympus medical systems corp.(omsc) received literature titled "perioperative complications of endoscopic submucosal dissection for early gastric cancer in elderly japanese patients 75 years of age or older".This study was conducted the endoscopic submucosal dissection (esd) for early gastric cancer on 307 patients between april 2004 and march 2009.The esds were performed by the subject device.In the literature, it was reported that 26 cases of bradycardia, 8 cases of perforation, and one severe bleeding have occurred.The patients with bradycardia were treated with administration of atroatropine.The patients of perforation were successfully treated with clipping, and the esd procedure was completed in all cases.Meanwhile, one patient of severe bleeding resulted in the discontinuation of esd.Based on the available information, detailed information of the subject device was not provided, and there is no description of the relationship between the events and the subject device.However, omsc assumes that severe bleeding might be related to the subject device since the subject device was used for submucosal resection.Therefore omsc assumes that the severe bleeding discontinued esd might be a reportable serious injury.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) for the severe bleeding.

• Brand Name: ELECTROSURGICAL KNIFE
• Common Device Name: 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: 10827381
• Report Number: 8010047-2020-08840
• Device Sequence Number: 11823711
• Product Code: GEI
• UDI-Device Identifier: 04953170037702
• UDI-Public: 04953170037702
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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-1L-1
• 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: 11/02/2020
• Initial Report FDA Received Date: 11/12/2020
• 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