MAUDE Adverse Event Report: OLYMPUS AMERICA, INC SINGLE USE ELECTROSURGICAL KNIFE KD-645

Model Number	KD-645L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported during a therapeutic peroral endoscopic myotomy for type ii achalasia, the subject device tip "fell off" during the procedure.There was no melting identified.The customer reported they were unable to locate the tip of the knife.The customer did not report if additional intervention was attempted, including diagnostic testing to locate the device.There was a forty (40) minute procedural delay and the procedure was completed with another device.The subject device was inspected prior to use and was determined to be in "excellent condition." due to the lack of information provided by the customer and the potential for the device tip to be unknowingly left in the patient, this will be reported as a serious injury.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-645
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 16735906
• Report Number: 2429304-2023-00066
• Device Sequence Number: 15169184
• Product Code: KNS
• UDI-Device Identifier: 04953170407857
• UDI-Public: 04953170407857
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/13/2023
• Report Date (Section F): 03/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: KD-645L
• Device Lot Number: 2ZK 05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS GENERATOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown