MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC GASTROVIDEOSCOPE

Model Number GF-UCT140-AL5

Device Problems Device Reprocessing Problem (1091); Device Contamination with Chemical or Other Material (2944); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus and inspected.In addition to evaluation, due to deformation of electrical connector, water tightness was lost.Objective lens had a scratch.The distal end had a scratch.The acoustic lens had a scratch.The adhesive on bending section cover was detached.Due to wear of angle wire, bending angle in up/down direction did not meet the standard value.Due to wear of angle wire, bending angle in left/right direction did not meet the standard value.Due to wear of angle wire, the play of right/left knob was out of the standard value.Connecting tube had a scratch.The scope cover had a scratch.Grip had a scratch.Suction cylinder was shaved.Forceps channel port was shaved.Switch button 1 was sticky.Universal cord had a scratch.Universal cord had a dent.The protector of universal cord on scope connector side had a scratch.Ultrasonic cable had a scratch.The ultrasonic cable had a dent.The scope connector had a scratch.Light guide cover glass had a dent.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus senior technical service engineer had a loaner asset (ultrasonic gastrovideoscope) returned with no complaint from by the end user.There was no report of patient harm.During incoming inspection, the forceps elevator had foreign material due to insufficient reprocessing.The foreign material was yellowish-brown in color, but its identity was unknown.This medwatch is being submitted to capture the reportable malfunction found during 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 observed foreign matter attached to the elevator could not be identified and the root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASONIC GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16606533
• MDR Text Key: 312299934
• Report Number: 3002808148-2023-02916
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K012080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT140-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2010
• 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