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

Model Number MAJ-891

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/20/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) confirmed the subject device to investigate the complaint.Omsc found that the brown foreign material adhered to the fitting part of the stopcock with the main body.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

The foreign material came from rust and chlorine based on a component analysis.Since the lot number of the subject device was unknown, olympus medical systems corp.(omsc) could not confirm device history record of the subject device.The exact cause of the reported phenomenon could not be conclusively determined.There is the possibility that chlorine come from chemicals that promote oxidation.

• 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: 12906952
• MDR Text Key: 285940340
• Report Number: 8010047-2021-15307
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2021

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 Model Number: MAJ-891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/01/2021
• 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: Unknown
• Patient Sequence Number: 1