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

Model Number	KD-650Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This reported event has been reported by the importer on mdr# 2951238 - 2020 - 00529.
Event or Problem Description
It is reported in the literature article titled "esd with double-balloon endoluminal intervention platform versus standard esd for management of colon polyps" appearing in the aug 2020 issue of endoscopy international, following a colonoscopy with double balloon endoluminal intervention using a pentax single-channel video endoscope, an olympus disposable distal cap, and an olympus single use electrosurgical knife, one patient experienced a bowel perforation.No information was provided regarding any treatment required as a result of this occurrence.There was no report of any olympus device malfunction.
Additional Manufacturer Narrative
This report is being updated to provide additional investigation findings.A device history record (dhr) review for this specific device could not be carried since no lot number was reported.Olympus does not ship any device that doesn't meet all design and quality specifications.Conclusion: there is no indication that the device malfunctioned.The reported event is an anticipated potential adverse outcome of the stated procedure.

• 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: 11078153
• Report Number: 8010047-2020-11038
• Device Sequence Number: 2702412
• Product Code: KNS
• UDI-Device Identifier: 04953170265778
• UDI-Public: 04953170265778
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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: Health Professional
• Device Model Number: KD-650Q
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/29/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/16/2021
• 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