XVS Straight Clamp AMCH00005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290113780002), received between Aug 25, 2020 and Aug 25, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE MOVEMENT OF THE CLAMP MAY CAUSE FOR INACCURATE REGISTRATION AND OR DISPLAY OF TRACKING INFORMATION, WHICH MAY LEAD TO SERIOUS INJURY. THE DISLOCATION OF THE CLAMP BY MUSCLE AND FASCIA WAS EVIDENT, HENCE, THE SURGEON PLACED THE CLAMP AGAIN AND REPEATED THE SCAN. IT IS SUSPECTED THAT THE CLAMP WAS NOT CLOSED AS REQUIRED. AUGMEDICS' PERSONNEL REVIEWED THE INSTRUCTIONS AND INDICATIONS OF COMPLETE CLAMP CLOSURE AGAIN WITH THE SURGEON. NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10446962 ↗
• InjuryAug 25, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE EVENT IS RELATED TO THE PROCEDURE PERFORMED ON (B)(6) 2020. THE SURGEON REPORTED THAT 3 OF THE SCREWS DEVIATED IN POSITION. THE FIRST SCREW INSERTED WAS ACCURATE. DURING THE INVESTIGATION IT WAS FOUND OUT THE SURGEON WAS WORKING THOUGH SMALL INCISION IN OPEN PROCEDURE WHICH CAUSED FOR CONSTANT REARRANGEMENTS OF RETRACTORS AND INSTRUMENTATION HANDLING IN CLOSE VICINITY OF THE CLAMP. THE AUGMEDICS REPRESENTATIVE SUSPECTS THAT THE CLAMP CLOSING SCREW WAS NOT FULLY TIGHTNENED. IT WAS CONCLUDED THAT THE CLAMP WAS NOT TIGHTEN ENOUGH BY THE SURGEON AND THEREFORE WAS MOVED BY THE HANDLING OF THE RETRACTOR OR INSTRUMENTATION THE 3 SCREWS WERE REMOVED AND REPLACED USING FLUORO. NO ADDITIONAL INTERVENTION WAS REQUIRED. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED. THE SURGEON WAS RE-TRAINED ON INDICATION FOR FULLY CLOSED CLAMP.

  Patient problems: Spinal Column Injury

  MAUDE report 10446961 ↗
• InjuryAug 25, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE EVENT IS RELATED TO THE PROCEDURE PERFORMED ON (B)(6) 2020. THE SURGEON REPORTED THAT 3 OF THE SCREWS DEVIATED IN POSITION. THE FIRST SCREW INSERTED WAS ACCURATE. DURING THE INVESTIGATION IT WAS FOUND OUT THE SURGEON WAS WORKING THOUGH SMALL INCISION IN OPEN PROCEDURE WHICH CAUSED FOR CONSTANT REARRANGEMENTS OF RETRACTORS AND INSTRUMENTATION HANDLING IN CLOSE VICINITY OF THE CLAMP. THE AUGMEDICS REPRESENTATIVE SUSPECTS THAT THE CLAMP CLOSING SCREW WAS NOT FULLY TIGHTENED. IT WAS CONCLUDED THAT THE CLAMP WAS NOT TIGHTEN ENOUGH BY THE SURGEON AND THEREFORE WAS MOVED BY THE HANDLING OF THE RETRACTOR OR INSTRUMENTATION. THE 3 SCREWS WERE REMOVED AND REPLACED USING FLUORO. NO ADDITIONAL INTERVENTION WAS REQUIRED. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED. THE SURGEON WAS RE-TRAINED ON INDICATION FOR FULLY CLOSED CLAMP.

  Patient problems: Spinal Column Injury

  MAUDE report 10446960 ↗