MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR

Model Number OER-PRO

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Olympus field service engineer (fse) was dispatched to the user facility.The lid was replaced.Equipment repaired and verified according to oem instructions.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.

Event Description

It was reported there was crack in the lid of the unit.There was no patient involvement.Per the customer, no additional information is available.

Manufacturer Narrative

The legal manufacturer reviewed the contents of this complaint.The legal manufacturer reported that the root cause has not been identified.However, the legal manufacturer reported that the probable cause for the reported event was as follows: the legal manufacturer reviewed the contents of this complaint.The legal manufacturer reported that the root cause has not been identified.However, the legal manufacturer reported that the probable cause for the reported event was as follows: based on photos provided from the customer, are such as the lid was contacted with a scope when it was closed, something hard hit the lid.Design of the device or manufacturing cannot be confirmed as factors to cause of the event.It was confirmed that the subject device was shipped in accordance with specifications.The ifu states in case cracks occurred on the lid, abnormality is detectable by conducting the following inspection states in chapter 3 inspection before use, 3.2 inspecting the lid and lid packing.· before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10431215
• MDR Text Key: 203700220
• Report Number: 8010047-2020-05670
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1