MAUDE Adverse Event Report: PIVOTAL HEALTH SOLUTIONS, INC DECOMPRESSION OF CHOICE; DOC

Model Number	E9011
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A weld on part e7130 appears to have failed and the piece of the table connected through the e7130 weld fell to the ground.
Additional Manufacturer Narrative
The device is being returned to manufacturer for evaluation.Evaluation of initial information appears it was likely there was a weld failure.
Event or Problem Description
A weld on part e7130 appears to have failed and the piece of the table connected through the e7130 weld fell to the ground.
Additional Manufacturer Narrative
The device and part e7130 were evaluated and a defect in the weld was identified as the root cause for the malfunction that occurred in this reported incident.

• Brand Name: DECOMPRESSION OF CHOICE
• Common Device Name: DOC
• Manufacturer (Section D): PIVOTAL HEALTH SOLUTIONS, INC; 3003 9th ave. sw; watertown SD 57201
• Manufacturer (Section G): PIVOTAL HEALTH SOLUTIONS, INC.; 3003 9th ave sw; watertown SD 57201
• Manufacturer Contact: julee driver ; 3003 9th ave sw; watertown, SD 57201 ; 6057530110
• MDR Report Key: 23291041
• Report Number: 3007278668-2025-00002
• Device Sequence Number: 20039811
• Product Code: ITH
• UDI-Device Identifier: 00852753008907
• UDI-Public: (01)00852753008907
• Combination Product (Y/N): N
• PMA/510(K) Number: K101889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: E9011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown