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

Model Number GIF-H190

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation and the investigation is in process.The olympus service center confirmed the reported event, the instrument channel was leaking.Additional findings included, the objective lens has a small edge chip and worn glue, the light guide lens had small edge chips and worn glue, the nozzle screw kept turning due to stripped threads, the bending section cover glue was cracked, the bending section was wet, the angulation was low, the control knob movement was loose, the insertion tube and boot were scratched, there was scratches on the scope connector (evis), the glue was worn on the plastic cover and there was a deep nick at the instrument channel.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

It was reported to olympus, the evis exera iii gastrointestinal videoscope was found during re-processing to have a hole in the insertion tube.The device was returned to olympus for repair.Olympus identified the nozzle screw kept turning due to stripped threads and determined there was a handling issue caused by insufficient cleaning.The aware date for this reportable event is the date of evaluation by olympus.No patient harm reported.

Manufacturer Narrative

This is a supplemental report to correct the initial mdr.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is not any evidence of foreign material exiting from the nozzle.Therefore, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 12005632
• MDR Text Key: 274932303
• Report Number: 8010047-2021-07565
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2018
• 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