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

Model Number	KD-650U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature title "cuffitis: is an endoscopic approach possible?".The literature reported the results of a study based on an endoscopic approach for the treatment of cuffitis as a complication of pouch anal anastomosis (ipaa), between march 2017 and august 2018.During the study period, a hybrid endoscopic submucosal dissection (esd) using an olympus instrument (unspecified dual knife) was performed on one patient with cuffitis after ipaa.The patient presented with rectal bleeding without hemodynamic instability and did not require a packed cell transfusion or hemostatic agents.The patient's treatment consisted of simple monitoring hospitalization, and the patient was discharged after 72 hours.Based on the available information, a direct relationship between the subject device and the observed adverse event could not be determined.

• 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: 10060667
• Report Number: 8010047-2020-02723
• Device Sequence Number: 2625529
• Product Code: KNS
• UDI-Device Identifier: 04953170265785
• UDI-Public: 04953170265785
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

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-650U
• 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: 04/21/2020
• Initial Report FDA Received Date: 05/15/2020
• 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
• Patient Age: 59 YR