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 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation.The cause of the issue is unknown at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

Event Description

The user facility reported that during reprocessing, it was found that the tightening ring of the subject device had separated with its internal metal parts and its outer plastic parts, and that the biopsy valve had been frequently clogged with the tightening rings.There was no report of patient injury associated with this event.No user injury was reported.This report is related to reports with (b)(4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Device inspection result is unavailable for no item return.Repair history review: maj-891 is accessory of endoscope and does not have repair menu.The subject item was not used on procedure since the suggested event was found at reprocessing.Root cause cannot be specified.Based on investigation and information gathered, it was presumed that glue between the metal parts and plastic parts deteriorated and peeled off by physical stress, chemical stress or the like.This is likely to be a cause of the suggested event.Feedback to user and sbc (site business center) below: the user facility experienced 3 similar cases including this one.Monitoring : to check user handling of maj-891 as below: - whether the user follow ifu (instruction for use).- whether the user apply physical stress or chemical stress to maj-891.Olympus will continue to monitor complaints for this device.

• 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: 12708525
• MDR Text Key: 284808370
• Report Number: 8010047-2021-13731
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MAJ-891
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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