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

Model Number GIF-H170

Device Problems Device Reprocessing Problem (1091); Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

"hole in forceps, foreign object (syringe tip) jammed " was reported on the device.The issue found at preparation for use.The device was replaced and the intended procedure was completed with similar device.There was no injury to the patient, and there was no delay in the procedure.No harm reported, no patient, no user injury reported due to the event.

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation found foreign material clogged in the k- channel (auxiliary channel).The reported issue of "syringe tip" jammed was confirmed.Furthermore, the following defects were identified during device inspection: angulation in the up direction out of standards due to worn of angle-wire water amount supply out of standards due to deformation of nozzle.Light guide (lg) lens broken, bundle condition not normal.The adhesive part of a-rubber (ar) damaged.A crumple at the connecting tube noted.Switches 1 and 2 (sw1 is deformed.Sw2 is deformed) air/water (aw cylinder) noted deformed.Suction cylinder deformed.S-cover deformed.Video cable protector damaged.The coating at the video cable noted peeled off.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

The customer reported reprocessing the scope properly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 root cause of from the reprocessing failure which caused the tip of the syringe to break in the biopsy channel could not be determined.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: 15975357
• MDR Text Key: 308526723
• Report Number: 9610595-2022-05403
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

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: 11/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 02/09/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• 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