MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE

Model Number GF-UE160-AL5

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

The customer originally returned their ultrasonic gastrovideoscope due to the pink rubber at the distal end being deteriorated.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.During the device evaluation, it was discovered that the probe unit was chipped with missing pieces.This report is being submitted to capture the chipped probe unit.

Manufacturer Narrative

(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 was confirmed, the pink rubber at the distal end was deteriorated.As noted in, the probe unit was discovered to be severely damaged with deep cuts and chipped pieces.Furthermore, the light guide cover lens was scratched.The probe unit acoustic lens was damaged.The distal end adhesive was defective.The bending tube and ultrasonic connector cover were worn out.The scope cover was cracked.The grip unit, connecting tube, and switch box unit were all scratched.The air/water nut as well as the suction cylinder nut had the paint peeling off.The universal cord and connector had chemical damage present.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to add information provided on the initial report.The following sections were corrected: g2, added "spain" 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 (acoustic lens cut), and it appeared to be due to external force applied to it.These conditions were determined to be likely due to physical stress by dropping and/or knocking the affected part to a hard surface/object and applying a chemical stress during the cleaning/sanitization process.The instruction manual identifies the following related verbiage which may help prevent the phenomenon: ¿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: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASONIC 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: 12953586
• MDR Text Key: 281868444
• Report Number: 8010047-2021-15665
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356261
• UDI-Public: 04953170356261
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K051541
• 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: 02/04/2022

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-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2012
• 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