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

Model Number MAJ-891

Device Problem Break (1069)

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

Event Date 11/03/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during an unspecified surgery assisted by endoscopy using the subject device for the patient, who suffered from cerebral infarction, left renal ureteral calculi with hydronephrosis, and infection, it was found that fluid was the spurted out from the connector of the subject device.Then, the user replaced the subject device with another similar device to complete the intended procedure.In addition, the user stated that the sealing ring of the subject device had been damaged, so the sealing ring was replaced to a new one, and the subject device could be used normally.There was no report of patient injury associated with this event.

Manufacturer Narrative

The subject device has not been returned to any of the olympus locations.Therefore, olympus could not investigate the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to any of the olympus locations.Therefore, olympus could not investigate the subject device.Olympus medical systems corp.(omsc) could not review the manufacturing history (dhr) of the subject device because the lot number of the subject device was unknown.And the device manufacture date was unknown.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from olympus china and the cautions described in the instruction manual, omsc surmised that the reported phenomenon occurred because the water tightness of the tightening ring became unsecured by damage to the biopsy valve, and also surmised that the cause of the biopsy valve damage might have been caused by interference with the endo therapy accessory and/or the cleaning brush.The instruction manual provides preventive measures against the reported failure mode.If additional information is received, this report will be supplemented.

• 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: 12982603
• MDR Text Key: 286132144
• Report Number: 8010047-2021-16013
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MAJ-891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Female