MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. GAS TUBE

Model Number MAJ-1741

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

The customer called olympus technical assistance center (tac) and inquired details on how often the maj-1741 gas tube used on the ucr needed to be cleaned.Tac called back and informed the customer that the gas tube must be cleaned and disinfected at least once per day according to the ucr manual.Tac proceeded to email the customer the ucr instructions for use.The customer mentioned using sterrad re-processor when performing reprocessing with the maj-1741.However, sterrad re-processor is not listed in the olympus ucr manual as an option.Tac instructed the customer to confirm with sterrad about validating the maj-1741 tube for their re-processor.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

Event Description

It was reported the gas tube reprocess is not performed according to the instruction manual.There was no patient involvement, no harm or user injury reported due to the event.

Manufacturer Narrative

This follow up report is being submitted to include the device history record(dhr) review results from the legal manufacturer investigation.The following sections were updated: d8, h6 and h10.The legal manufacturer performed the dhr review for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.The probable cause of defective reprocess of the gas tubing is due to the operators misunderstanding of the cleaning frequency described in the instruction manual.As a result, the malfunction occurred.The instructions for use (ifu) states: clean, disinfect, or sterilize the case at least once the day is over.Olympus will continue to monitor complaints for this device.

• Brand Name: GAS TUBE
• Type of Device: GAS TUBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12110311
• MDR Text Key: 263585341
• Report Number: 8010047-2021-08357
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 04953170239120
• UDI-Public: 04953170239120
• Combination Product (y/n): N
• PMA/PMN Number: K063786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1741
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MAJ-1741