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

Model Number GIF-HQ190

Device Problem Mechanical Problem (1384)

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

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the issue was not confirmed.The air/water supply passed the capacity test.All switches were scratched.The distal end plastic cover had dents and the pin was old.The objective lens and light guide lens had old glue.The nozzle pin was old.There was low angulation and scratches at the light guide lens tube, connector, and s-cover.The labeling was peeling and illegible.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported by the customer, during reprocessing of the evis exera iii gastrointestinal videoscope, two (2) metal pieces were jammed in the part where the water goes through the scope (air/water supply).No patient involvement reported.

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 to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, it is likely that a part of peripheral device which was used in combination with the subject scope entered the air/water channel.It is also likely that foreign material left in the air/water channel clogged the nozzle by inadequate reprocessing on the channel.A definitive root cause cannot be identified.Ifu (reprocessing manual) specifies about inspection prior to use for the distal end as below: ¿3.3 inspection of the endoscope 8.Inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities.¿ ifu (operation manual) specifies about inspection prior to use for the water feeding function as below: ¿3.8 inspection of the endoscopic system inspection of the objective lens cleaning function depress the valve.Observe the endoscopic image and confirm that water flows on the entire objective lens.After checking the water feeding function and while observing the endoscopic image, feed air by covering the hole in the air/water valve with your finger.Confirm that the emitted air removes the remaining water from the objective lens and clears the endoscopic image.¿ ifu (reprocessing manual) specifies about nozzle reprocessing to be taken immediately after procedure e as below: ¿5.3 precleaning the endoscope and accessories flush the air/water channel with water and air: caution to prevent clogging of the air/water nozzle of the endoscope, flush water into the air channel of the endoscope, using the aw channel cleaning adapter (mh-948) after each patient procedure.¿ olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA III 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: 12466909
• MDR Text Key: 271271319
• Report Number: 8010047-2021-11684
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

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: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• 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