MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES

Model Number MAJ-1500

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

The subject maj-1500 has not been returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

The user found the pin within the connector of the maj-1500 was broken.So it is possible that reprocessing of the endoscopes were insufficient.There was no patient injury report related to the event.

Manufacturer Narrative

The subject maj-1500 was not returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined.Based on device investigation results of similar events reported in the past, the pin was likely broken due to degradation and excessive force.The instruction manual provides of maj-1500 provides warnings and how to inspect the device prior to use as follows.Warning over time, the connecting tube will deteriorate because it is subject to wear with each use.If any of the following are found with the connecting tube, do not use it and replace it with a new one.Connecting a defective tube could prevent the effectiveness of the cleaning and high-level disinfection process.Inspection visually inspect the pin of the connecting tube to ensure that there are no bends or breaks.

• Brand Name: CONNECTING TUBE
• Type of Device: ENDOSCOPE REPROCESSOR ACCESSORIES
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9155344
• MDR Text Key: 217692851
• Report Number: 8010047-2019-03494
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170233937
• UDI-Public: 04953170233937
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

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: No Information
• Device Model Number: MAJ-1500
• Device Lot Number: 2121547
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1