MAUDE Adverse Event Report: UNKNOWN FORCEPS, ENT

Device Problem Insufficient Information (3190)

Patient Problems Cerebrospinal Fluid Leakage (1772); Brain Injury (2219)

Event Date 03/05/2015

Event Type  Injury  

Event Description

The reported event was that the surgeon noted that a csf leak was created while using an unknown brand of giraffe "forceps.The leak was repaired with a frozen cartilage graft.A post-operative head imaging study (presumably a ct scan) revealed a pneumocephalus.The patient reported a headache the following day.There was no report of additional intervention or sequelae related to the event.The acclarent device used during this procedure (relieva? spin balloon sinuplasty? system) functioned as expected with no malfunction noted.Acclarent concluded from the complaint investigation that an mdr was not required as there was no evidence to suggest that the acclarent product contributed to the patient event, and there was no device malfunction that could cause or contribute to death or serious injury.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FORCEPS, ENT
• Type of Device: FORCEPS, ENT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17516461
• MDR Text Key: 321063271
• Report Number: MW5123410
• Device Sequence Number: 1
• Product Code: KAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1