MAUDE Adverse Event Report: MEDTECH ROSA® BRAIN; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 3.0.1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 09/26/2019

Event Type  malfunction  

Event Description

During a procedure, upon verifying our registration, the pointer probe inadvertently caused a superficial laceration.The rosa was emergently disconnected.The surgeon feels there is no relationship of the occurrence to a previously released recall.

• Brand Name: ROSA® BRAIN
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTECH; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 9494826
• MDR Text Key: 172009480
• Report Number: 9494826
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 03760244031754
• UDI-Public: (01)03760244031754
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.0.1
• Device Catalogue Number: ROSAS00303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2019
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other