MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-Q260J

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation found the angle wires were found stretched , due to wear of angle wire, bending angle in up direction does not meet the standard value.Due to wear of angle wire, the play of up/down knob is out of the standard value.The reported issue of "u angle down" (reduced angulation) was confirmed.Furthermore, as noted , device evaluation found a screw in the operation part came off and caused the angulation becomes locked-cannot disengage.Additionally, the following defects were identified during device inspection: electrical connector (el-connector) and control unit has discoloration due to water leakage.Control unit has corrosion due to water leakage.Adhesive on a-rubber (adhesive connection) has a chip.Due to deformation of bending tube, the angle knob torque of right/left knob at free (play) exceeds the standard value.C-cover (distal end) has a scratch.Connecting tube has a scratch.Grip has a scratch.Universal cord has a scratch.Scope connector (s-connector) has a scratch.Scope cover (s-cover) has a scratch.Switch 3 (sw3) has a scratch.Right/left knob has a scratch.Up/down knob has a scratch.Forceps elevator (fe) knob and lever has a scratch.Protector of universal cord on s-connector side has a scratch.The suction cylinder (s-cylinder) was scraped with a cleaning brush (handling issue).Paint on s-cylinder noted peeled.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Company representative returned the loaner device with a repair request noted with an issue of 'u angle down" (reduced angulation).There was no patient involvement on this reported issue.No harm was reported.No user injury reported.Device evaluation found a screw in the operation part (control section) came off, was missing and caused the angulation becomes locked-cannot disengage.This report is being submitted due to the finding of screw came off from the operation part and cause the angulation becomes locked-cannot disengage (mechanical problem) identified during device return evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct h4.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 suggested event could not be concluded, although it can be presumed that the defect was caused due to repeated stress such as shocks and shakes were applied to the scope.The event can be detected/prevented by following the inspection method for the event is described as follows in ¿chapter 3 preparation and inspection, section 3.2 inspection of the endoscope¿ as below."[inspection of the endoscope]" "[inspection of the bending mechanisms]".Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL 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: 16755723
• MDR Text Key: 313495867
• Report Number: 9610595-2023-06251
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/25/2023

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-Q260J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2008
• 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