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

Model Number MAJ-891

Device Problem Material Separation (1562)

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

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: ((b)(6) hospital); added here due to character limitation in respective field.

Event Description

It was reported, the forceps/irrigation plug (isolated type) had a separation of the metal and resin parts of the cap was confirmed.The issue occurred during an attempt to clean it.The procedure was completed using the same set of equipment.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.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was returned to olympus for inspection, and the customer's complaint separation of the metal and resin parts of the cap was confirmed.Based on the results of the investigation, it is likely the following led to the malfunction: when removing it from the scope, excessive stress was applied to the t-tube body, may cause it to malfunction.The adhesive part of the tightening knob deteriorated due to repeated reprocessing.Furthermore, the adhesive swelled and deteriorated due to storage with moisture attached or storage in a humid environment.The following are included in the instructions for use (ifu): instruction manual chapter 4 operation: to disconnect the forceps/irrigation plug, hold only the locking ring, and loosen it until it comes off the endoscope.Do not turn the plug¿s housing, as it may damage the plug and the endoscope.Chapter 8 storage: do not store the forceps/irrigation plug in direct sunlight and/or in a place exposed to x-rays.Otherwise, the forceps/irrigation plug may be damaged, or an infection control risk may arise.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19218172
• MDR Text Key: 341635561
• Report Number: 9610595-2024-08959
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: OER-6-OLYMPUS ENDOSCOPE REPROCESSOR