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

Model Number MAJ-1500

Device Problem Mechanical Problem (1384)

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

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

The subject maj-1500 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc started the evaluation.The exact cause of the reported event could not be conclusively determined at this time.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the user found the pin within the connector of the subject maj-1500 was broken when the user check connection tube.The user reported that they did not know when the pin broke.The user was using the subject maj-1500 that is pin broken.There was no patient injury report related to the event.

Manufacturer Narrative

This is a supplemental report to provide device evaluation results.The subject maj-1500 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc performed evaluation of the subject maj-1500 to find that a pin of the equipment side connector was broken.It was also found that the appearance of the connector was faded and that the tube was hardened.Judging from the similar cases reported in the past, the pin of the connector might be broken due to forcible force being applied to the pin.The following inspection before use is included in the instructions for use for the subject device: ·visually inspect the pin of the connecting tube to ensure that there are no bends or breaks.

• Brand Name: CONNECTING TUBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 7039891
• MDR Text Key: 93094143
• Report Number: 8010047-2017-01797
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

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-1500
• Other Device ID Number: 04953170233937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 11/24/2017
• Supplement Dates FDA Received: 12/20/2017
• 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