MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. HD ENDOEYE LAPARO-THORACO VIDEOSCOPE

Model Number LTF-VH

Device Problems Corroded (1131); Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, the customer's originally reported issue of a e315 scope error was confirmed; the source was observed to be corrosion on the video plug.The following additional findings were also noted: assorted chips, crack, peeling, angulation out of specification, image noise due to a damaged charge-coupled device, and a failure of switch 3 due to damage.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported that their hd endoeye laparo-thoraco videoscope alarmed an error e315 (non-compatible endoscope).The malfunction reportedly occurred during an unknown diagnostic procedure, which was completed using another device.The device reportedly had been inspected before use.There were no reports of patient or user harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide results of the investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication that the event was caused by a misuse or that the event was related to design of the device.Repair history was reviewed and no issues were found related to the reported event.The device was noted to be previously repaired in january 2022.Although a definitive root cause of the defect could not be identified, it was determined that the defect was likely caused by breakage of the image sensor unit including disconnection by stress of repeated use, external factors, or handling or that the components including ic chip and capacitor, mounted on the electric circuit board, had a defect.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

• Brand Name: HD ENDOEYE LAPARO-THORACO VIDEOSCOPE
• Type of Device: LAPARO-THORACO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16595533
• MDR Text Key: 312033447
• Report Number: 9610595-2023-04875
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170287015
• UDI-Public: 04953170287015
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1