MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 SP STEPPING HEAD; BRACHYTHERAPY EQUIPMENT & ACCESSORIES

Model Number	D01000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the serial number for the device was provided, a review of the device history records is currently being performed.The return of the device is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during a procedure, the in-out wheel allegedly slipped when locked.There was no reported patient injury.

• Brand Name: SP STEPPING HEAD
• Common Device Name: BRACHYTHERAPY EQUIPMENT & ACCESSORIES
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• MDR Report Key: 11045086
• Report Number: 2020394-2020-20892
• Device Sequence Number: 19148686
• Product Code: ITX
• UDI-Device Identifier: 00801741078873
• UDI-Public: (01)00801741078873
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K972152
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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: D01000
• Device Catalogue Number: D01000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/21/2020
• 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