MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number MAJ-891

Device Problems Mechanical Problem (1384); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that there was the brown foreign material on the joint portion of the stopcock.As a result of the analysis of component, the brown foreign material was corrosion.Omsc concluded that the metal part of the stopcock was corroded and then the gap generated on the joint portion, consequently the lever became looser than an initial product.Omsc also concluded that the corrosion on the joint portion of the stopcock was caused by the oxidation due to the residue of chemicals.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user facility that while disassembling the subject device during the reprocessing, it was found that the lever of the subject device was looser than usual.The user facility did not provide other detailed information.There was no report of patient injury associated with this event.

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Type of Device: FORCEPS/ IRRIGATION PLUG
• 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: 10991203
• MDR Text Key: 220981632
• Report Number: 8010047-2020-10230
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/11/2020

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
• Device Operator: No Information
• Device Model Number: MAJ-891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/11/2020
• 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: Unknown
• Patient Sequence Number: 1