MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number 1884008

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned for evaluation.Product analysis has not been performed.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that in the beginning of the uppp procedure, the blade tip broke inside the tube.There were no fragments, but a new blade had to be used to complete the procedure.There was no patient injury as a result.

Manufacturer Narrative

The blade was returned for analysis; during the analysis the customer report of a broken tip was not confirmed.There was damage to the hub in the locking areas caused by the locking mechanism of the handpiece.The hub damage is consistent with not being securely loaded into the handpiece, which prevented the drive mechanism of the handpiece to engage the inner hub chevrons.When loaded into a test handpiece, the blade was secured and operated in oscillation mode at 1500 rpm.As it relates to the complaint, there were no functional defects or breakages found with the returned sample blade.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 7298522
• MDR Text Key: 101025851
• Report Number: 3004209178-2018-04017
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 20681490047481
• UDI-Public: 20681490047481
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884008
• Device Catalogue Number: 1884008
• Device Lot Number: HG1SQRR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1