MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MOUTHPIECE

Model Number MAJ-674

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tooth Fracture (2428)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to any of olympus locations.Therefore, olympus could not investigate the subject device.The exact cause of the reported event could not be conclusively determined.However, based upon the information from the user there was the possibility that the reported phenomenon was attributed to the following.The instruction manual of the endoscope which is used with the subject device states that "confirm the patient¿s dental condition before using the mouthpiece.If any irregularity, such as teeth under treatment or lack of teeth is observed, the teeth may be broken".Therefore the phenomenon described in the instruction manual of the endoscope such as above mentioned might have been occurred.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed as follows by the user.The patient who underwent the upper endoscopy experienced discomfort for the tooth at a later date and consulted the dentist and found that the base of tooth was broken in the alveolar ridge.The subject device had been attached to the patient during the upper endoscopy, and the upper endoscopy had been completed without any problems.The user facility did not provide other detailed information.

• Brand Name: MOUTHPIECE
• Type of Device: MOUTHPIECE
• 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: 11846157
• MDR Text Key: 253611977
• Report Number: 8010047-2021-06472
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAJ-674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other