MAUDE Adverse Event Report: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD OLYMPUS; ENDOSONIC MOUTHPIECE

Model Number MAJ-1632

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tooth Fracture (2428)

Event Date 07/23/2015

Event Type  Injury  

Manufacturer Narrative

Device has been discarded.

Event Description

The maj-1632 is a single-use mouthpiece, intended for use during upper gi endoscopy to protect the flexible endoscope from being bitten and the patient's gums and lips from trauma.The maj-1632 is intended for use in medical facilities under the direction of a trained physician.Keymed (medical & industrial equipment) ltd has been made aware of an event in a (b)(6) healthcare facility where a patient injury has occurred.When the mouthpiece was removed post esophagogastroduodenoscopy (egd) procedure, the patient's tooth was broken.The patient injury was a result of post procedure removal of the mouthpiece.The mouthpiece has been discarded.The broken piece of tooth (fragment size not confirmed) was found in the patient bed at the healthcare facility.The patient has undergone a chest x-ray at the healthcare facility, the result of the x-ray is clear , therefore no portion of the broken tooth remains in the patient.

Manufacturer Narrative

The subject device was not returned to keymed ltd.The following potential root causes were investigated: manufacturing defect; design issue; and use error (2 possible types).Manufacturing defect - the mouthpiece has not been returned and the batch is unknown.Therefore no manufacturing fault analysis can be undertaken.However, there are no other reported instances and due to the injection moulding process used, it would be expected that the whole batch would contain common defects.The ifu states the following caution: 'caution: do not use a mouthpiece that is damaged or deformed.Doing so may cause patient injury and/or equipment damage.Confirm that the mouthpiece and strap are free from cracks, deformations, discoloration or other irregularities.' although it is unknown whether the check was performed or acted upon.In conclusion, a manufacturing defect is unlikely to be the cause of this event.(b)(4).The height of the portion that enters the patient mouth is 1.6 to 2.0mm larger than the predecessor, but it is doubtful this would increase the likelihood of damage to teeth.The design intent of the mouthpiece is such that it is not expelled accidently during use.In conclusion, a design issue is unlikely to be the cause of this event.Use error - patient tooth was weak prior to the procedure and care was not taken.The ifu states the following caution: 'before using the mouthpiece, check the condition of the patients teeth.In case of any irregularity, take additional care to prevent further trauma' it is unknown whether this check was performed or acted upon.In conclusion, it is possible that this type of use error is the cause of this event.Use error - forced removal of mouthpiece caused tooth to break.The description of event in accompanying email from olympus canada includes 'the patient injury was a result of post-procedure removal, with propofol sedation making it difficult for the patient to expel the device from their mouth on their own.' there is no guidance in the ifu to take care when removing the mouthpiece.A caution will be added to the ifu advising users that care should be taken when removing the mouthpiece to prevent injury in the oral cavity.In conclusion, it is probable that this type of use error is the cause of the event, possibly in conjunction with the use error type above.

Event Description

The maj-1632 is a single use-use mouthpiece intended for use during upper gi endoscopy to protect the flexible endoscope from being bitten and the patients gums and lips from trauma.The maj-1632 is intended for use in medical facilities under the direction of a trained physician.Keymed ( medical & industrial equipment) ltd has been made aware of an event in an (b)(6) healthcare facility where a patient injury has occurred.When the mouthpiece was removed post esophagogastroduodenoscopy (egd) procedure, the patient's tooth was broken.The patient injury was a result of post procedure removal of the mouthpiece.The mouthpiece has been discarded.The broken piece of tooth (fragment size not confirmed) was found in the patient bed at the healthcare facility.The patient has undergone a chest x-ray at the healthcare facility, the result of the x-ray is clear, therefore no portion of the broken tooth remains in the patient.

• Brand Name: OLYMPUS
• Type of Device: ENDOSONIC MOUTHPIECE
• Manufacturer (Section D): KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD; keymed house; stock road; southend on sea, essex SS2 5 QH; UK SS2 5QH
• Manufacturer (Section G): KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD; medical device manufacturing; centre, journeyman's way; temple farm industrial estate, essex SS2 5 TF; UK SS2 5TF
• Manufacturer Contact: alison prior ; keymed house; stock road; southend on sea, essex SS2 5-QH ; UK SS2 5QH ; 702616333
• MDR Report Key: 5002933
• MDR Text Key: 22945235
• Report Number: 9611174-2015-00005
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAJ-1632
• Device Catalogue Number: K10020960
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: No
• 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