MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number MAJ-891

Device Problem Melted (1385)

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

Event Date 04/15/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.E1/establishment name: (local independent administrative agency kobe municipal hospital organization kobe municipal medical center central municipal hospital); added here due to character limitation in respective field.

Event Description

It was reported, the forceps/irrigation plug (isolated type) had the shaft part of the cock that melted in such a way that it stuck to the sterilization pack.The issue occurred at reprocessing.The procedure was completed using a similar device.There were no reports of delay, patient harm, injury, or death.Additional details relating to the patient and the event have been requested, but no response has been received at this time.

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Type of Device: FORCEPS/ IRRIGATION PLUG
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19217136
• MDR Text Key: 341826183
• Report Number: 9610595-2024-08951
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• 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: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2024

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: Health Professional
• Device Model Number: MAJ-891
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• 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