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

Model Number GIF-H180J

Device Problem Partial Blockage (1065)

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

Event Type  malfunction  

Manufacturer Narrative

Upon inspection and testing, issue of the wire, possibly a wire from a brush, sticking out of the biopsy port and blocking instrument channel was observed.Minor scratches were noted.In addition, there was a leak in the instrument channel.Evaluation is ongoing.Supplemental report(s) will be submitted when any information becomes available.

Event Description

The device was returned for inspection and repair, when the issue of the wire sticking out of the biopsy port and blocking instrument channel was observed.There is no reported harm to any patient.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates in sections: e2, e3, g3, g6, h2, h4, h6, and h10.Due diligence was executed for this event with no information provided by the customer.The device history record review confirmed that device conformed to specifications at the time of shipping.The subject device was not repaired within the past one year.It was seemingly a cleaning brush that had become stuck in biopsy channel.It is possible that this brush had a coating over the coil/wire that had come loose and bunched up in the channel causing the blockage.The subject device has been reprocessed before being sent to olympus.The biopsy port was not able to be attached to the subject device, and the suction function was not able to be confirmed because wire protruded out of the biopsy port.Since the wire protruded out of biopsy port was likely a cleaning brush, the cleaning brush may have broken by deterioration or forcible use by the user.In addition, the following was observed for the device: leakage from biopsy channel, insulation failure at distal end cover, forceps passage failure; sw1 and 2 rubber cut, insertion section scratched/snaky by foreign material lodged in biopsy channel, universal cord dented/scratched, insufficient angulation and play on angulation control knob was excessive.All labels were peeled off.

• Brand Name: EVIS EXERA II 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: 11863012
• MDR Text Key: 251930553
• Report Number: 8010047-2021-06603
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170275449
• UDI-Public: 04953170275449
• Combination Product (y/n): N
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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: No Information
• Device Model Number: GIF-H180J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1