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

Model Number MAJ-891

Device Problems Melted (1385); Physical Resistance/Sticking (4012)

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

Event Date 06/18/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the device has not been provided at this time.The subject device has been returned to olympus for evaluation and the reported issue was confirmed.A review of the device history record (dhr) could not be performed due to the serial number being unknown.Based on the results of the investigation, it is likely that, the reported issue was due to problem on chemicals in manual cleaning, such as the use of chemicals at high concentrations without the correct dilution conditions of the chemicals and failure of autoclave with chemical residue.The root cause could not be identified.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus, during reprocessing, when the forceps/irrigation plug (isolated type) was sterilized in an autoclave (132 degrees, 5 minutes) under the sterilization conditions specified in the instruction manual, the shaft of the cock melted in such a way that it stuck to the sterilization pack.There was no harm or user injury reported due to the event.Patient identifier: (b)(6) and (b)(6) capture related events.

• 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: 17332196
• MDR Text Key: 320023860
• Report Number: 9610595-2023-10174
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/17/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/17/2023
• 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: Initial
• Patient Sequence Number: 1