MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB CONICAL GUIDE DRILL 3+4 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number SURGEQUIP

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on august 28, 2018, by cochlear ltd.On behalf of cochlear americas.Registration number (b)(4).Exemption number (b)(4).

Event Description

Per the clinic, it was reported that during surgery (date not reported) the surgeon was unable to remove the guide drill from the hand piece resulting in the surgeon to discontinue use of the device.The surgery did not proceed.There is no report of patient injury associated with this event.

Manufacturer Narrative

This report is filed on november 27, 2018.

• Brand Name: CONICAL GUIDE DRILL 3+4 MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke 43533 ; SW 43533
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7821310
• MDR Text Key: 118398776
• Report Number: 6000034-2018-01793
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SURGEQUIP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention