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

Model Number GIF-Q180

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the service center for evaluation.The service group found the free engage and the right left control knobs move together.The angulations were below specifications and the up/down/left/right control knobs were loose.Additionally, the scope failed the leak test from the biopsy channel and also between the objective lens and distal end cover.The insertion tube was buckled below the protective boot.There was a cut on switch button number.The bending section cover adhesive at the distal end was cracked and there was a halo on the image.A review of the scope's service history indicated the scope was purchased on (b)(6) 2008 with no previous repair records.The cause of the reported malfunction could not be determined at this time as the investigation is ongoing, however, if additional information becomes available this report will be supplemented accordingly.

Event Description

The service center was informed by the customer that during reprocessing, when the evis exera ii gastrointestinal video scope's large dial is turned, it turns to lock position.No patient harm or injury was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on legal manufacturer's final investigation.The following sections were updated: g4, g7, h6, h10.Based on the legal manufacturers investigation, the suggested event was not reproduced during incoming inspection for repair by sbc.For this reason, it was difficult to specify the cause.According to investigation result 1-3, it was confirmed that when the right/left angulation knob was turned, the right/left angulation lock was also turned.Judging from this phenomenon, when the user turned the right/left angulation knob, the right/left angulation lock was also turned, and the bending section became locked unintentionally, and then, it resulted in suggested event.The possible cause of turning the right/left angulation lock along with turning the right/left angulation knob was as follows; internal components, such as the click spring, was worn and torn by due to long-term use of the subject device.As a result, a mechanism to prevent turning the right/left angulation knob and the right/left angulation lock together was impaired.

• Brand Name: EVIS EXERA II 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
• MDR Report Key: 10781826
• MDR Text Key: 224481432
• Report Number: 8010047-2020-08475
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170307522
• UDI-Public: 04953170307522
• Combination Product (y/n): N
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GIF-Q180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1