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

Model Number GIF-H170

Device Problems Mechanical Problem (1384); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation has confirmed the reported issue.Evaluation found damage nozzle.Due to damage, water removal ability does not meet the standard value.In addition, as stated in section b5, the nozzle was found clogged with foreign materials.The foreign materials described to be resembles of a fiber type material and there was a rigid plastic like material clogging the nozzle unit noted to be not fully removable.Furthermore, the following defects were identified during device inspection: due to wear of fe lever, up/down knob cannot be locked securely.Aw-cylinder (air/water cylinder) has discoloration.Suction cylinder (s-cylinder) has discoloration.Due to wear of angle wire, bending angle in up direction does not meet the standard value.Due to wear of angle wire, the play of right/left knob is out of the standard value.Video cable has a buckling.Electrical contact of video connector shaved.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer reported with an issue of "device has inversion and air problems".No harm was reported.No patient harm, no user injury reported.Device evaluation found foreign material clogged in the device nozzle.This report is being submitted due to the finding of foreign material clogged in the device nozzle found during device return evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to h4.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 the foreign material was insufficient cleaning.Identification of the material 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: 17223336
• MDR Text Key: 318451456
• Report Number: 9610595-2023-09478
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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: 06/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 09/04/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2018
• 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