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

Model Number GIF-H180

Device Problem Material Deformation (2976)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

The customer originally returned his evis exera ii gastrointestinal videoscope due to a dilation balloon getting stuck in the distal end of the scope during reprocessing.This event had no patient involvement.During the device evaluation, it was discovered that the forceps passage was restricted due to buckling of the bending section and insertion tubing.This report is being submitted to capture the deformed bending section and insertion tubing discovered during the device evaluation.

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus.However; investigation is ongoing.During the device evaluation, a leak was discovered in the instrument channel, with minor scratches on the distal end.The distal end adhesive was cracked.The forceps passage was restricted due to buckling of the bending section and insertion tube.The suction flow rate was low for the same reasons.The light guide tube was also buckled and a stretched wire was providing low angulation.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Manufacturer Narrative

Repeated attempts were performed to obtain additional information from the reporter, but were not successful.If additional information is obtained at a later date, a supplemental report will be submitted.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.Based on the results of the investigation, a definitive root cause could not be determined.The following is included in the instructions for use (ifu) and may have helped prevent the event: ¿avoid aspirating solid matter or thick fluids; instrument channel, suction channel, or suction valve clogging can occur.If the suction valve clogs and suction cannot be stopped, disconnect the suction tube from the suction connector on the endoscope connector.Turn the suction pump off, detach the suction valve, and remove solid matter or thick fluids.If the suction valve clogs and the suction cannot be used when solid matter, such as the clip or thick fluid, are aspirated, withdraw the endoscope, and disconnect the suction tube from the suction connector on the endoscope connector.Attach a syringe containing sterile water to the suction connector.Straighten the insertion tube as much as possible and forcefully flush the connector with the water while the suction valve of the endoscope is slightly depressed.Repeat the flush until the thick fluid or solid matter are discharged from the distal end of the suction channel.After discharging, confirm that there is no irregularity in the suction function according to ¿inspection of the suction function¿, before using the endoscope again.If the thick fluid or solid matter cannot be discharged, stop using the suction function and contact olympus.¿ olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14278273
• MDR Text Key: 299565163
• Report Number: 8010047-2022-07504
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339776
• UDI-Public: 04953170339776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100584
• 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: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2007
• 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