MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-HQ190

Device Problem Partial Blockage (1065)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the service center for evaluation.The customer¿s report of ¿ foreign material exiting from the air/water nozzle restriction at tip of scope tight¿ was not confirmed.There was no issue found forceps passage and air/water supply.The nozzle was found worn and requires glue.Deep scratches were noted on the bending section rubber.The bending section glue was found cracked on the cover and insertion tube.This investigation is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that during an unspecified procedure, foreign material was exiting from the air/water nozzle causing restriction at the tip of the scope.It is unknown if the intended procedure was completed.There was no patient injury reported.

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.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, since detailed information regarding the foreign material was not provided, it is likely the foreign material was chemical residue or a part of silicon rubber used in injection tube/endoscopic room, which are accessories of the subject device.All efforts to contact the user for further information have been unsuccessful to-date.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11201821
• MDR Text Key: 227945631
• Report Number: 8010047-2021-01649
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

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: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1