Stealth® Clamps A3205Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607915112714), received between Apr 5, 2017 and Apr 5, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2017Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN - THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE (B)(4) INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION. ADDITIONAL CERS CREATED 2017-0423, 2017-0463, 2017-0464, 2017-0465, 2017-0466, 2017-0467, 2017-0468, 2017-0469, 2017-0470, 2017-0471, 2017-0472, 2017-0473, 2017-0474. TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462392 ↗
• MalfunctionApr 5, 2017Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN - THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION ADDITIONAL CERS CREATED (B)(4). TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462391 ↗
• MalfunctionApr 5, 2017Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN - THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION. TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462384 ↗
• MalfunctionApr 5, 2017Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN - THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT TO MAINTAIN THE CLAMP IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14, 2017 FROM THE CUSTOMER VIA EMAIL: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462374 ↗