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

Model Number GF-UCT180

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, the echo head on the evis exera ii ultrasound gastrovideoscope ¿seems to be loose, and the area of the echo crystals is damaged.¿ during the inspection of the returned device, there was a missing piece from the pink probe unit.There were no reports of patient harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation of damaged and loose ¿echo crystals¿ was confirmed.It was determined that the pink probe was missing a chip in the rubber.In addition, there was a leaking distal end and connector pin, a cracked distal end, a gap in the acoustic lens, a cracked and scratched charged coupled device lens, loose glue on the bending section cover and a broken and wrinkled connecting tube.The side cover was cracked, the scope body and grip were both heavily dented and the switch button (number one) was cut.The universal cord was broken and angulation and break were found to be insufficient.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to g2.G2 - checked "other" to correct country to spain.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 cause of the missing piece from the pink probe unit likely occurred due to stress and/or handling the device.The specific root cause could not be determined at this time.The following information is stated in the instructions for use: "3.2 inspection of the endoscope.5.Inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, peeling, scratches, holes, sagging, transformation, bends, adhesion of foreign body, detached, parts, protruding objects, or any other irregularities.".Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 07-nov-2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• 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: 13057136
• MDR Text Key: 286353672
• Report Number: 8010047-2021-16554
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K093395
• 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,Followup
• Report Date: 12/07/2022

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: 11/22/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 02/19/2022; 11/08/2022
• Supplement Dates FDA Received: 03/10/2022; 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2019
• 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