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

Model Number K10020960

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.Olympus followed up with the user facility regarding the reported event and was informed by the facility¿s endoscopy manager that the patient had a pre-existing dental issue as the affect teeth had been bonded in place.The cause of the reported event cannot be conclusively determined.The instructions for use advise users ¿when placing the mouthpiece into the patient's mouth, take care to avoid placing fingers between the mouthpiece and the patient's teeth.Before using the mouthpiece, check the condition of the patient's teeth.In case of any irregularity, take additional care to prevent any further trauma.Care should be taken when removing mouthpiece to prevent injury in the oral cavity.¿.

Event Description

Olympus received a medwatch report that states a patient's left bottom teeth fell out when the certified registered nurse anesthetist removed the mouthpiece, after an emergency esophagogastroduodenoscopy (egd) procedure.The facility¿s scrub rn had inserted the mouthpiece at the beginning of the procedure without issue.A chest x-ray was ordered in pacu to make sure no other teeth had come out during the procedure and gone down into his lungs.No foreign body identified on x-ray.

• 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: 8506735
• MDR Text Key: 141724345
• Report Number: 2951238-2019-00729
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/11/2019
• 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
• Patient Age: 61 YR
• Patient Weight: 81