MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA TRANSNASAL ESOPHAGOVIDEOSCOPE

Model Number	PEF-V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for investigation.The device evaluation confirmed the user report of a separated distal end of the device.Additionally, a leakage was noted from the bending section cover of the device, and there was a crack in the light guide lens.Based on device inspection results, damage to distal section of the device is most likely caused by improper handling.The ifu states the following ¿important information ¿ please read before use: warnings and cautions: do not apply shock to the distal end of the insertion tube, particularly the objective lens surface at the distal end./ do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.¿ the review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.As a result of the device investigation, olympus has concluded that the damage to the device was likely caused by improper handling.Olympus will continue to monitor the field performance of this device.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
Event or Problem Description
As reported, the distal end cover of the visera transnasal esophagovideoscope was damaged.According to the initial reporter, the rubber at the distal tip was been pulled off.This event occurred during reprocessing and therefore had no patient involvement.

• Brand Name: VISERA TRANSNASAL ESOPHAGOVIDEOSCOPE
• Common Device Name: TRANSNASAL ESOPHAGOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11230519
• Report Number: 8010047-2021-01889
• Device Sequence Number: 17045942
• Product Code: FDS
• UDI-Device Identifier: 04953170340376
• UDI-Public: 04953170340376
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K001766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: PEF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1