MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problems Device Contamination with Chemical or Other Material (2944); Scratched Material (3020); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation of leakage was confirmed.The allegations of image freezing and control knob being loose were not confirmed.During evaluation of device, it was noted switch 1, 2 and 3 did not function, suction cylinder was shaved, nozzle was clogged, angle wires were stretched, bending tube was deformed, bending section cover adhesive was detached, objective lens was scratched, light guide lens was dirty, distal end was scratched, light guide cover glass was dirty, control body switch was corroded, switch box was discolored, scope connector cover was scratched, grip was scratched, color ring was cracked, light guide bundle was broken, channel tube was damaged, control unit and scope connector was corroded from water leakage, ultrasonic cable was damaged and acoustic lens was scratched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the evis exera ii ultrasound gastrovideoscope image auto freeze and released during an unknown diagnostic procedure.The procedure was completed successfully and there was no report of patient harm associated with this event.Via a call, the engineer observed air/water leakage from the suction channel and angulation control knob felt too loose.During inspection of the returned device, forceps elevator had foreign material and acoustic lens had a scratch which reached to glue layer.This mdr is being submitted to capture the reportable malfunction found during device 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.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the foreign material was unable to be identified.Additionally, it¿s likely the scratched acoustic lenses were due to physical stress such as falling or tapping.The root cause of the physical stress to the scratched acoustic lens was unable to be identified.The events can be prevented by following the instructions for use which state: ¿chapter 5 reprocessing: general policy.5.3 precautions: warning: all channels of the endoscope, including the elevator wire channel and balloon channel, must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.¿ ¿important information ¿ please read before use.Warnings and cautions.Warning: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope 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.Caution: do not coil the insertion tube or universal cord with a diameter of less than 12 cm.Equipment damage can result.Do not attempt to bend the endoscope¿s insertion section with excessive force.Otherwise, the insertion section may be damaged.Do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15546968
• MDR Text Key: 306453461
• Report Number: 3002808148-2022-02797
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170341793
• UDI-Public: 04953170341793
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2013
• 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