MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H170

Device Problems Mechanical Problem (1384); Material Too Rigid or Stiff (1544)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation found the reported issue of "no video output" was not confirmed, however, noise occurred due to damage on the video connector.The video connector was noted to be polluted.The light guide connector found deformed and corroded.The light guide lens were found broken.Crease at the ccd lens were noted, discoloration on lens observed.Furthermore, inspection found the insertion tube is stiff due to damage of the connecting tube.Connecting tube protector noted to be damaged (physical defects/damage).Additionally, the following were identified during device inspection: insulation resistance at the tip is out of standards due to scratch of c-cover.Liquid leaks due to breakage of s-cover.Damage on switches observed (switch 3, switch 4).Water cleaning function is out of standards due to deformation of nozzle.The adhesive part of a-rubber (ar) is broken.There is crumple at the connecting tube.Crease, crumpling found on video cable.Air/water (aw cylinder) found deformed including the suction cylinder.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Company representative reported with an issue of "no video output", found during preparation for use.No harm was reported.The device was replaced and the intended procedure was completed using a similar device.There was no injury to the patient, and there was no delay in the procedure.No user injury reported.Device evaluation found the device insertion part is stiff due to damage of the connecting tube.This report is being submitted due to the finding of insertion tube defects (physical defects of the bending section and insertion tube including unusual shapes) identified during device return evaluation.

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.Based on the results of the investigation, the reported :¿no video output¿ could not be reproduced/confirmed, however, the insertion site was found to be stiff due to damage to the connecting tube.The root cause of the damage connecting tube could not be determined but the damage was likely the result of user handling, physical stress caused the insertion tube to break.The event may be detected by following the instructions for use for: inspection of the endoscope inspection of the flexibility adjustment mechanism the event may be reduced/prevented by following the instructions for use which state: ¿do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video cable, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video cable, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient¿.Olympus will continue to monitor field performance for this device.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16199133
• MDR Text Key: 307723784
• Report Number: 9610595-2023-00921
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170334115
• UDI-Public: 04953170334115
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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-H170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2020
• 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