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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the evaluation of the returned mouthpieces.The user facility returned 68 brand new maj-1632 lip press endoscope mouthpieces for evaluation.It was reported that the injury is related to the device dimension being too long down into the mouth.Four out of 68 maj-1632 mouthpieces were opened and inspected.A dimension measurement was performed; the aperture size measures within standard at 22mm (height) x 27mm (width).Fingertips were run through the edges of the mouthpieces to feel for any sharp edges, cracks and inconsistencies; none was observed.However, the inner side openings of the mouthpiece are not smooth to the touch.Based on the evaluation, the reported complaint could not be confirmed as the user facility did not send the actual mouthpiece that was used during the procedure.No obvious physical anomalies noted on the 68 brand new maj-1632 lip press endoscope mouthpieces.These returned mouthpiece will be forwarded to the oem for further analysis.This report will be supplemented if new information becomes available.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information provided by oem.The oem performed the analysis on the 68 brand new devices that were returned.There was no differences found in any of the parts.The exact cause cannot be identified.There were no differences found between the devices returned.

• 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
• MDR Report Key: 8224759
• MDR Text Key: 132341483
• Report Number: 2951238-2019-00330
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MODEL ENDOSCOPE
• Patient Outcome(s): Other