MAUDE Adverse Event Report: INORIS MEDICAL SP. Z.O.O. CLIP-ON BITEGUARD; ENDOSCOPIC BITE BLOCK

Model Number P/N KZ200693

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Sore Throat (2396); Low Oxygen Saturation (2477)

Event Date 06/19/2019

Event Type  Injury  

Event Description

Pt had a watchman procedure done, pt was returned to the recovery area and started to complain about throat irritation and showed some drop in oxygen level, rn preformed a mouth assessment and noticed a foreign object in the throat which was removed and identified as the bile guard used during the transesophageal monitoring of the heart.This guard is concerning due to the size and the lock of attached secured strip to hold it in place.There was no further harm done to the pt.This device was removed from the surgery par level.Fda safety report id# (b)(4).

• Brand Name: CLIP-ON BITEGUARD
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): INORIS MEDICAL SP. Z.O.O.
• MDR Report Key: 8739576
• MDR Text Key: 149515901
• Report Number: MW5087646
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P/N KZ200693
• Device Catalogue Number: H45521CB
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 88