MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA LLL GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-XP190N

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device inspection and evaluation , service repair noted the following findings: connecting and bending tubes separated with a-rubber ripped.Several traces of humidity at the connector area.In addition, the following defects were found on the device : grip is sticky, s-cylinder has discoloration.Color ring has a crack, u/d (up/down) knob has scratch, and switch has a scratch obtained.Sc cover unit has a dent.Circuit board unit in s-connector, plug unit has corrosion due to water leakage.Outside shield unit has corrosion due to water leakage, cable unit, s-case unit has corrosion due to water leakage.Due to a crack on c-cover, insulation resistance value at distal end does not meet the standard value.Ig protector is damaged, lg lens dirty, cracked, universal cord has scratch.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer opened a repair request with fault description "instrument sleeve repair".There is no patient involvement associated on this event.Device return evaluation found connecting and bending tubes separated with a-rubber ripped (metal visible).This report is being submitted for bending section detached from the connecting tube.

Manufacturer Narrative

The initial medwatch.The aware date should be 27-jan-2022.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, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to the following: excessive torque was applied to the bending section by user handling, which caused the soldering area to detach.Strength of the soldering area became reduced by repeated reprocessing, which caused the soldering area to detach.The user can prevent / reduce the suggested event by handling device in accordance with the following instructions for use(ifu): "important information: please read before use.Warnings and cautions: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope 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 twist or bend the bending section with your hands.Equipment damage may result." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA LLL GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13582953
• MDR Text Key: 296462449
• Report Number: 8010047-2022-03399
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305313
• UDI-Public: 04953170305313
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K123317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

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: GIF-XP190N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2019
• 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