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

Model Number OER-PRO

Device Problems Crack (1135); Mechanical Jam (2983)

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

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Field service engineer (fse) inspected the loading tray assembly.Fse noted that the locking mechanism appeared to be damaged, thereby not engaging the tray properly and causing it to bind when pulling and pushing the tray in and out.Fse replaced the entire chemical loading tray assembly.Fse verified the assembly was now fully functional and adjusted front and rear bottle sensor positions according to the technical guide.Fse removed and replaced cracked lid and performed lid alignment, confirming no fluid was leaking from the lid gasket.Fse also installed new printer door and basin sensor covers, and gas filter case.Equipment was repaired and verified according to other equipment manufacturing instructions.Software attributes have been verified and confirmed.Equipment passed the electrical safety test.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

As reported for this event by the customer, the device chemical loading tray was very hard to pull and even jammed.The chemical loading tray did not lock in place at times.In addition, the device lid had a crack.There is no harm reported to any patient.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12136287
• MDR Text Key: 273769648
• Report Number: 8010047-2021-08598
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• 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: 07/08/2021

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: OER-PRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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