MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-655

Model Number KD-655L

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported that when using an evis lucera gastrointestinal videoscope, there was fire at the plastic distal end cover causing burns to the patient¿s stomach.The event occurred during the pre-labeling phase of a therapeutic procedure (esd) and the c02 air pump was used to supply the gas at the time of the incident.There was no procedural delay, or no further patient harm reported with the event.The procedure was finished with another set of device.The patient was hospitalized for further treatment.Additional information regarding the event has been requested but not received at this time.This event requires three reports, as all devices were used during the event: patient identifier (b)(6) is for the videoscope.Patient identifier (b)(6) is for the electrosurgical knife.Patient identifier c23555710 is for the hf unit.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-655
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18336057
• MDR Text Key: 330609381
• Report Number: 9614641-2023-01918
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170377488
• UDI-Public: 04953170377488
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K171158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2023

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
• Device Operator: Health Professional
• Device Model Number: KD-655L
• Device Lot Number: 31K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GIF-Q260J.; HF UNIT ESG-400.
• Patient Outcome(s): Hospitalization