MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. MAJ-1632 MOUTHPIECE (BOX 50 PCS); ENDOSCOPIC BITE BLOCK

Model Number K10020960

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

The mouthpiece device has not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.To prevent patient injury, the device instructions document cautions that the patient¿s teeth be checked before device placement, and recommends that dentures or denture plates be removed.The instructions document also has directions for pre-procedure inspection of the device, including inspection for deformation and damage, and verification of expiration date.The instructions document also cautions that during the procedure the clinician should, ¿monitor patient during use to ensure no injury is caused by the mouthpiece in the oral cavity.¿ also during removal, ¿care should be taken when removing mouthpiece to prevent injury in the oral cavity.¿ to avoid deterioration of the device during storage, ¿store the device in a clean, dry, well ventilated room, maintained at ambient temperature.Do not store the mouthpiece in direct sunlight, at high temperature, in high humidity, or exposed to x-rays and/or ultraviolet-rays.Doing so could damage the mouthpiece.¿.

Event Description

Olympus was informed that during an unknown endoscopic procedure, the mouthpiece device for the unknown model endoscope caused a cut on the outside of the patient¿s lip.It was reported that the injury was related to the device dimension being too long down into the mouth.There was no excessive bleeding and no further patient intervention.

• Brand Name: MAJ-1632 MOUTHPIECE (BOX 50 PCS)
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend-on-sea, essex SS2 5 QH; UK SS2 5QH
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8224762
• MDR Text Key: 132342200
• Report Number: 2951238-2019-00331
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K10020960
• Device Lot Number: 20183750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other