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

Model Number GIF-Q260

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus service center for evaluation.During inspection and testing, service could not confirm or duplicate the customer's reported issue (right/left angulation was locked).Service found the adhesive of the bending section was deteriorated and cracked due to external factors.The paint on the air/water cylinder and the suction cylinder was peeled off.There were stains that were difficult to remove on the operation part, switch box, operation part cover, right/left knob, the scope connector side of the universal cord, and the scope connector, due to handling and insufficient cleaning.Water damage was observed on the electrical connector.The forceps stopper was scraped due to an external factor.The operation part cover was loose.The following components were scratched due to external factors: insertion section, operation part, tip cover, switch #1, switch box, operation part cover, up/down knob, right/left knob, grip, universal cord, scope connector side of the universal cord, scope connector, and the right/left angulation lock knob.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported the right/left angulation of the subject device was locked and could not be disengaged.There was no patient or user injury reported due to the event.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.

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 the reported device problem.A definitive root cause for this issue was not established.However, it is probable that the issue occurred due to wear on the angulation wire caused by a strong twisting operation to the left and right with the bending section angulation fixed.It is also probable that the issue occurred due to an irregular load such as a sudden angulation operation.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA 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: 14190460
• MDR Text Key: 299056058
• Report Number: 8010047-2022-06914
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

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-Q260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 07/20/2022
• Supplement Dates FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2002
• 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