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

Model Number MAJ-891

Device Problems Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)

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

Event Date 08/20/2021

Event Type  malfunction  

Event Description

The user returned the forceps/irrigation plug maj-891 to olympus because of a leakage from the plug maj-891. When the user replaced it with another plug, there was no problem, and the same phenomenon occurred with the same type of plug maj-891 on the same day at the user facility. Olympus medical systems corp. (omsc) inspected the vicinity of the part where the watertightness of the plug maj-891 was not maintained, and found that foreign material was adhered to the mating surface between the male part of the stopcock and the stopcock part. Therefore, the poorly reprocessed plug maj-891 may have been used in the procedure. There was no report of patient injury associated with the event.

Manufacturer Narrative

The forceps/irrigation plug maj-891 was evaluated at omsc. Omsc checked the watertightness of the forceps/irrigation plug and found that air bubbles were leaking near the stopcock. Furthermore, omsc confirmed the vicinity of the part where the watertightness was not maintained, and found that foreign material was adhered to the mating surface between the male part of the stopcock and the stopcock part. Therefore, it is possible that water leakage from the forceps/irrigation plug occurred due to the change in the watertight condition between the male part of the stopcock and the stopcock part. Omsc attempted to analyze the composition of foreign material, but could not analyze it due to the small amount of sample. Osmc was unable to review the device history record because the lot number and manufacturing date of the forceps/irrigation plug maj-891 are unknown. If additional information becomes available, 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: 12945399
• MDR Text Key: 285982295
• Report Number: 8010047-2021-15627
• 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: 12/07/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/06/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown