MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

Model Number LTF-S190-5

Device Problems Crack (1135); No Display/Image (1183); Mechanical Problem (1384); Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation found no image would appear when testing the device.There was also leaking confirmed at the a-rubber (sheath covering the bending section) due to missing glue and a crack at the distal end body of the device causing a sharp edge.The a-rubber itself was found to be a non-olympus part.There was also a non-olympus patch on the lg tube and a non-olympus video cable was being used.The switches for the device were also found to not be working.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

During the evaluation of a returned endoeye flex deflectable videoscope, it was found that no image would appear when testing the device.The device was returned due to failing a leak test during reprocessing.No patient harm or impact to patient care was reported due to the leaking.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), a review of the instructions for use (ifu), as well as a historical trending analysis were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿do not strike, hit, or drop the endoscope¿s distal end, rigid portion, bending section, control section, universal cord, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, rigid portion, bending section, control section, universal cord, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient¿ do not insert the video connector while the electrical contacts are wet and/or dirty, which may result in an electric shock, causing severe damage to the endoscope and compromising patient and/or operator safety¿ turn the video system center on only when the video connector is connected to the video system center.In particular, confirm that the video system center is off before connecting or disconnecting the video connector.Failure to do so can result in equipment damage, including destruction of the image sensor.¿ an evaluation of the device noted the distal end was severely damaged, which led investigation to think that excessive physical stress was applied to the distal end.This stress probably caused malfunction of the charged couple device unit or the charged couple device cable, ultimately leading to no image presenting on the display.Olympus will continue to monitor the field performance of this device.

• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11708240
• MDR Text Key: 246987958
• Report Number: 8010047-2021-05252
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310355
• UDI-Public: 04953170310355
• Combination Product (y/n): N
• PMA/PMN Number: K080948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1