MAUDE Adverse Event Report: STORZ ENT FORCEPS ALLIGATOR

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

The patient, a (b)(6) child, presented with hoarseness and persistent otitis media on multiple outpatient visits.An elective ambulatory procedure was scheduled and the patient underwent bilateral tube placement and laryngoscopy on (b)(6) 2013 without complications.Of note, prior to the procedure, the tip of the alligator forceps appeared to have broken apart from the bottom; the bottom part was found on the floor and both pieces were retrieved.There was no harm to the patient, and he was discharged home following the procedure on (b)(6) 2013.

• Brand Name: ENT FORCEPS ALLIGATOR
• Type of Device: ENT FORCEPS
• Manufacturer (Section D): STORZ
• MDR Report Key: 3619226
• MDR Text Key: 15174702
• Report Number: MW5034232
• Device Sequence Number: 1
• Product Code: KAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 18