UNKNOWN MCEN272

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-31 for UNKNOWN MCEN272 manufactured by Unknown.

Event Text Entries

[35297893] Em performing procedure and the pediatric backbiter broke. From surgical note-attention was now turned to the left maxillary sinus. The illuminating guide wire was fed into the left maxillary sinus followed by the dilating catheter which was then inflated to 12 atmospheres. Upon deflating and removing the catheter, the resulting antrostomy was then further enlarged using a 2. 9 mm microdebrider. A pediatric back biter was used to enlarge the ostium by removing the bone of the anterior portion of the neo ostium. Here the jaw of the instrument fractured and the anvil of the instrument became embedded in the soft tissue. Multiple attempts were made to remove it using right angle forceps and curved needles but the fragment just migrated deeper into the soft tissue near the inferior/medial aspect of the left orbit. I decided not to risk injury by further exploration as the fragment was in a safe area. On (b)(6) 2015-post op visit: surgeon discussed with patient about pediatric back biter instrument fracturing during patient's surgery. I made multiple attempts to remove fragment during surgery but fragment migrated deeper and i was unable to localize. I discussed the pro's and con's with removing it. Patient at this time is unsure on whether she wants to remove and will discussed further at next post op visit. On (b)(6) 2015 follow up visit: surgeon had a long discussion with the patient and her mother regarding the metal instrument fragment and the fact that it's location is in an area that is difficult to access but also an area where it will likely remain inert and cause no ill effects. I suggested that there is a possibility it will migrate out on its own and that we will perform plain x-rays to determine if it remains. If she desires its removal a ct with image guidance protocol will be required. On (b)(6) 2015 follow up visit patient advised of and shown actual plain x rays which reveal no metallic foreign body present in the facial/sinus area. The following occurred during this office visit: endoscopy type: nasal endoscopy. Procedure details: after topical anesthesia and decongestion, the patient was placed in the sitting position. The zero degree telescope was passed along the left nasal floor to the nasopharynx. It was then passed into the region of the middle meatus, middle turbinate, and the sphenoethmoid region. An identical procedure was performed on the right side. The following findings were noted as stated below: findings: sinuses are clear- no scabbing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5058915
MDR Report Key5347478
Date Received2015-12-31
Date of Report2015-12-31
Date of Event2015-08-16
Date Added to Maude2016-01-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNKNOWN
Generic NameDEBRIDER/PEDIATRIC BACKBITER
Product CodeKAE
Date Received2015-12-31
Model NumberMCEN272
Catalog NumberUNK
Lot NumberUNK
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2015-12-31

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