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

Model Number	GIF-V70
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The device evaluation confirmed the customer's report and removed the broken piece of brush from the suction channel.In addition, service found additional issues.The suction cylinder was worn.The insulation resistance at the tip was out of specification due a scratched cap cover.The up/down knob was loose, and the up direction was out of specification due to wear of the angle wire.A liquid leak was observed due to a damaged air/water cylinder, and the water pressure was out of specification due to deformation of the nozzle.The light guide (lg) lens was broken, and the lg-bundle was in poor condition.The adhesive rubber was broken.The connecting tube was creased.Corrosion was observed at the electrical connector due to leakage and switch #1 was damaged.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The user facility reported that after reprocessing, while preparing the device for use, it was observed that a section of a disposable brush was broken and inside the suction channel of the gastrointestinal videoscope.There was no delay of the intended diagnostic procedure.The procedure was completed using another similar device with no patient impact reported due to the event.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The device evaluation confirmed the customer's report and removed the broken piece of brush from the suction channel.In addition, service found additional issues.The suction cylinder was worn.The insulation resistance at the tip was out of specification due a scratched cap cover.The up/down knob was loose, and the up direction was out of specification due to wear of the angle wire.A liquid leak was observed due to a damaged air/water cylinder, and the water pressure was out of specification due to deformation of the nozzle.The light guide (lg) lens was broken, and the lg-bundle was in poor condition.The adhesive rubber was broken.The connecting tube was creased.Corrosion was observed at the electrical connector due to leakage and switch #1 was damaged.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The user facility reported that after reprocessing, while preparing the device for use, it was observed that a section of a disposable brush was broken and inside the suction channel of the gastrointestinal videoscope.There was no delay of the intended diagnostic procedure.The procedure was completed using another similar device with no patient impact reported due to the event.
Additional 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 19 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.As documented within the investigation results, the cleaning brush became broken during reprocessing prior to use.Therefore, the cause of this suggested phenomenon was presumed as follows: the brush was broken due to its unfitting diameter to the channel diameter, brush deterioration or the like; or, the brush was broken due to the brush being hooked by the suction cylinder due to wear.Then, the broken part was left inside the biopsy channel.The reprocessing method at the facility differed from the instructions for use (ifu) recommendation.The ifu states: "insert the endo therapy accessory through the biopsy valve.Confirm that the endo therapy accessory extends smoothly from the distal end of the endoscope.Also, make sure that no foreign objects come out of the distal end of the endoscope." olympus will continue to monitor field performance for this device.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: 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: 13506279
• Report Number: 8010047-2022-02738
• Device Sequence Number: 6009493
• Product Code: FDS
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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
• Operator of Device: Health Professional
• Device Model Number: GIF-V70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2002
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown