MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE DISTAL ATTACHMENT

Model Number D-201-11804

Device Problem Fire (1245)

Patient Problem Gastroesophageal Burn (4475)

Event Date 11/20/2023

Event Type  Injury  

Event Description

The customer reported, when using a disposable distal attachment, 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.This event requires four reports.The related patient identifiers are as follows: patient identifier (b)(6): videoscope.Patient identifier (b)(6): electrosurgical knife.Patient identifier (b)(6): hf unit.Patient identifier (b)(6): disposable distal attachment.This medwatch represents patient identifier (b)(6): disposable distal attachment.

Manufacturer Narrative

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

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Type of Device: DISPOSABLE DISTAL ATTACHMENT
• 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: 18564391
• MDR Text Key: 333488668
• Report Number: 9614641-2024-00149
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170278280
• UDI-Public: 04953170278280
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K984358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-201-11804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2023
• 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: ELECTROSURGICAL KNIFE; HF UNIT; VIDEOSCOPE
• Patient Outcome(s): Hospitalization