MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES HYSTEROFIBERSCOPE

Model Number HYF-XP

Device Problems Device Reprocessing Problem (1091); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As part of the investigation, olympus followed up with the user facility to obtain additional information/clarification on the reported event but with no results.The original equipment manufacturer (oem), performed a device history record review and no abnormalities were noted.The actual product was manufactured on january 10, 2019.A review of the service records show the scope was purchased on (b)(6) 2019 and was last serviced via repair on (b)(6) 2020.No device was returned to the oem and insufficient information was provided; therefore, the oem was unable to investigate the cause leading to the occurrence of this incident.The instructions for user provides the following information: chapter 3 preparation and inspection before each case, prepare and inspect this instrument as instructed below.Inspect other equipment used with this instrument as instructed in their respective instruction manuals.Should the slightest irregularity be suspected, do not use the instrument, see chapter 9, ¿troubleshooting¿.If the irregularity is still suspected after consulting chapter 9,contact olympus.Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage.This instrument was not disinfected or sterilized before shipment.Before using this instrument for the first time,reprocess it according to the instructions in chapter 5,¿reprocessing: general policy¿ through chapter 7,¿cleaning, disinfection and sterilization procedures.

Event Description

The service center was informed that during reprocessing, tiny specks are showing up on the lens of the scope and foreign material is falling off from the channel.There was a small leak observed during an air leak test.No patient injury or harm was reported.

• Brand Name: OES HYSTEROFIBERSCOPE
• Type of Device: HYSTEROFIBERSCOPE
• 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: 10766548
• MDR Text Key: 225205172
• Report Number: 8010047-2020-08358
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04953170411571
• UDI-Public: 04953170411571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K891451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HYF-XP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2019
• 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