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

Model Number GF-UCT180

Device Problems Peeled/Delaminated (1454); Material Split, Cut or Torn (4008)

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

Event Date 10/25/2021

Event Type  malfunction  

Event Description

The customer reported to olympus, the evis exera ii ultrasound gastrovideoscope was leaking around the seal at the ultrasound tip during reprocessing.The intended procedure was therapeutic.During the inspection of the returned device, the glue on the forceps cover was peeling and there was a gap in the rubber of the pink probe.There were no reports of patient harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during evaluation.

Manufacturer Narrative

The device was returned for evaluation and the customer¿s allegation was confirmed.The device was leaking at three locations.The device was leaking at the gap in the rubber of the pink probe unit, the forceps passage due to the tear marks and at the cracked glue on the bending section cover.The forceps cover glue was peeling, the insulation test for the plastic distal cover and probe unit provided an inconsistent reading and scope connector was loose.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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 6 years since the subject device was manufactured.Based on the results of the investigation, the phenomenon are likely attributed to stress.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This supplemental report is submitted to provide additional information obtained from the customer.A supplemental report will be submitted if additional information is received.

Event Description

Additional information was obtained from the customer.The procedure that was going to occur after the reprocessing was completed using a similar device.The subject device is leak tested after every use.

• 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: 12958264
• MDR Text Key: 284178714
• Report Number: 8010047-2021-15711
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2022

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: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 12/10/2021; 01/13/2022
• Supplement Dates FDA Received: 12/22/2021; 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2015
• 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