Suction Irrigation System C6001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607915116989), received between May 26, 2016 and Oct 24, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NO INFORMATION. DETAILED DESCRIPTION OF EVENT: "HOLE/TEAR IN PACKAGING. ITEM WAS OPEN ONTO STERILE FIELD WITHOUT NOTICING THAT THERE WAS A HOLE/TEAR IN THE PACKAGING, THUS CONTAMINATING THE STERILE FIELD AND CONSUMABLES". ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: OPEN ANOTHER PACK. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996357 ↗
• MalfunctionFeb 18, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: WHEN THE STERILE MEDICAL DEVICE WAS OPENED (SUCTION IRRIGATION SET), WE SAW A HAIR THAT WAS HALF INTERIOR HALF EXTERIOR OF THE STERILE MEDICAL DEVICE. MATERIAL NOT USED. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 11-FEB-2022: I DIDN¿T MANAGE TO REACH THE PERSON IN CHARGE OF THE FILE. NORMALLY, THE DEFECTIVE DEVICE IS SENT BACK TO AMERSFOORT TODAY. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: MATERIAL NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13564942 ↗
• MalfunctionApr 15, 2021Partial Blockage; Partial Blockage

  PROCEDURE PERFORMED: NI. DURING PROCEDURE, SUCTION HANDPIECE TIP BLOCKED WITH A METAL PIECE AND IT CAME OFF WHEN THEY STARTED SUCTIONING. THIS HAPPENED IN 2 CASES (SECOND COMPLAINT TO COME, BACK TO BACK SURGERIES). INTERVENTION: NI. PATIENT STATUS: PATIENT IS FINE, AND COMPLETELY UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11674986 ↗
• MalfunctionApr 15, 2021Partial Blockage; Partial Blockage

  PROCEDURE PERFORMED: LAP APPENDIX. DURING PROCEDURE, SUCTION HANDPIECE TIP BLOCKED WITH A METAL PIECE AND IT CAME OFF WHEN THEY STARTED SUCTIONING. ITEM FROM THE LAP APPENDIX KITS. INTERVENTION: NI. PATIENT STATUS: PATIENT IS FINE, AND COMPLETELY UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11673583 ↗
• MalfunctionJul 11, 2016Sticking; Increase in Suction; Sticking; Increase in Suction

  HEPATECTOMY - "IN SURGERY AFTER HALF HOUR, THE RED BUTTON WAS STUCK SO THAT CANNOT STOP SUCTION BUT THE BLOOD UNABLE TO DRAW." TYPE OF INTERVENTION - UNKNOWN. PATIENT STATUS - "FINE" .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5784391 ↗
• MalfunctionMay 26, 2016Suction Problem; Suction Problem

  LAPAROSCOPIC APPENDECTOMY - "IN SURGERY, THIS DEVICE WAS AUTOMATIC SUCTION AND LEAK WHEN CLIENT DID NOT PRESS THE BUTTON." PATIENT STATUS - "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5683819 ↗