MCIVOR MOUTH GAG FRAME *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-28 for MCIVOR MOUTH GAG FRAME * manufactured by Pilling Surgical.

Event Text Entries

[291788] Pt with obstructive palatine tonsils underwent a tonsillectomy. A mcivor mouth gag was placed, and the right tonsil was removed without incident. Bleeding was controlled with cautery. The identical procedure was carried out on the left side, and according to the operative note, a burn was noticed to the left anterior tongue that appeared to have occurred by transduction of electrical current through the mouth gag. The burned area was approx 1 x 2cm in dimension but was very superficial. The non-viable tissue was excised and the wound was closed with sutures. The surgeon believes that better design of the instruments so that they are insulated would have prevented this injury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 474110
• MDR Report Key: 474110
• Date Received: 2003-07-28
• Date of Report: 2003-06-01
• Date of Event: 2003-05-01
• Date Added to Maude: 2003-07-30
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MCIVOR MOUTH GAG FRAME
• Generic Name: MOUTH GAG FRAME
• Product Code: KBN
• Date Received: 2003-07-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: ORDER 461126
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 462956
• Manufacturer: PILLING SURGICAL
• Manufacturer Address: 200 PRECISION ROAD SUITE 200 HORSHAM PA 19044 US

Device Sequence Number: 2

• Brand Name: BLADES
• Generic Name: OTHER
• Product Code: KBN
• Date Received: 2003-07-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: ORDER 461128, 461129, 461127
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 469135
• Manufacturer: PILLING SURGICAL
• Manufacturer Address: 200 PRECISION ROAD SUITE 200 HORSHAM PA 19044 US

Device Sequence Number: 3

• Brand Name: SABRE 2400
• Generic Name: BIPOLAR ESU
• Product Code: GEI
• Date Received: 2003-07-28
• Model Number: SABRE 2400
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 470074
• Manufacturer: CONMED
• Manufacturer Address: * * *
• Baseline Brand Name: ASPEN SABRE 2400
• Baseline Generic Name: ELECTROSURGICAL UNIT
• Baseline Model No: SABRE 2400
• Baseline Catalog No: 60-5600-002
• Baseline ID: NA
• Baseline Device Family: SABRE 2400
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K905654
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-07-28