MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

Report source: other '(b)(6)'.The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user report could not be confirmed.Water/air leakage was coming from the balloon connection unit (bcu) because it was damaged, not the switch body or key tops.Additionally, as noted, the distal end of the device was cracked with a gap noted.Furthermore, a missing piece had fallen off the probe unit.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer originally returned their evis exera ii ultrasound gastrovideoscope due to a water/air leakage from the switch box and switch key tops during preparation for use.According to the initial reporter, the intended procedure was completed using another device.There was no patient harm or consequence reported as a result of this event.During the device evaluation, damaged in the form of a crack was discovered in the distal end of the unit.This report is being submitted to capture the damaged distal end of the device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.Report source, added "(b)(6)" to the "if other, specify" field.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 legal manufacturer's investigation, multiple scratches were found at the distal end, and it is seemingly due to external force applied to it.The damage or deformation found were likely due to chemical stress during reprocessing which was attributed to mishandling.The information below was obtained from the investigation: probe unit acoustic lens damaged; probe unit acoustic lens peel off; guide pipe leak; light guide cover lens broken; image guide cover lens scratched; distal end damaged; a-rubber cementing defect; connecting tube kinked; grip unit cracked; air /water nut painting peel off; ks-mouthpiece corroded; suction cylinder nut painting peel off; guide pipe leak; switch box unit scratched; universal cord chemical damage; scope connector cover wear and tear; angulation wire play; biopsy channel deposit; air/ water leakage from the switch box and switch key tops.The instruction manual identifies the following related verbiage which can help prevent the indicated phenomena.¿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.¿ 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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12920242
• MDR Text Key: 285830831
• Report Number: 8010047-2021-15436
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/14/2022

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: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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