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

Model Number	HYF-XP
Medical Device Problem Codes	Device Reprocessing Problem (1091); Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: HYSTEROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10766548
• Report Number: 8010047-2020-08358
• Device Sequence Number: 3358736
• Product Code: HIH
• UDI-Device Identifier: 04953170411571
• UDI-Public: 04953170411571
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K891451
• 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): 10/30/2020

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: Other
• Device Model Number: HYF-XP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1