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

Model Number LTF-VH

Device Problems Degraded (1153); Mechanical Problem (1384); Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation found deformation of the video connector, due to deformation, watertigtness is lost.Air leak inspection failed.The reported issue of "air/water leakages" was confirmed.Furthermore, as stated in section b5, device evaluation found the adhesive of the objective lens were peeled off.This condition attributed due to deterioration, physical stress.Additionally, the following defects were identified during device inspection: a-rubber (insertion section) has a scratch.Adhesive on a-rubber (adhesive connection) has a chip.Video connector case has a crack.Switch 1 (sw1) has a cut.Due to wear of angle wire, bending angle in up direction does not meet the standard value.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Company representative sent a repair request reported with an issue of " air/water leakages".No harm was reported.No patient harm, no user injury reported.Device evaluation, the adhesives around the objective lens were peeled off.This report is being submitted due to the finding of adhesives around the objective lens were peeled off (deterioration, physical stress) identified during device return evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified; however, the event likely occurred due to use stress, external factors, or handling.The inspection method for this event is described as follows in the instructions for use "chapter 3 preparations and inspections 3.2 preparations and inspections of the endoscope"."[external inspection of the endoscope body] 1.Confirm that there are no scratches, chips, dirt, gaps around the lens, etc.On the objective lens and illumination lens at the tip." olympus will continue to monitor field performance for 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: 16782740
• MDR Text Key: 313737751
• Report Number: 9610595-2023-06463
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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: 03/28/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2011
• 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