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

Model Number D01000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

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 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
• Type of Device: BRACHYTHERAPY EQUIPMENT & ACCESSORIES
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer (Section G): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11045086
• MDR Text Key: 222649934
• Report Number: 2020394-2020-20892
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741078873
• UDI-Public: (01)00801741078873
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: D01000
• Device Catalogue Number: D01000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other