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

Model Number	3.0.1
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTECH; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 9494826
• Report Number: 9494826
• Device Sequence Number: 1942571
• Product Code: HAW
• UDI-Device Identifier: 03760244031754
• UDI-Public: (01)03760244031754
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2019
• Report Date (Section F): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 12/11/2019