Premium Trocar System C0600Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00607915114831), received between Jul 26, 2016 and Oct 7, 2017 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2017Gas/Air Leak; Gas/Air Leak

  PROCEDURE PERFORMED: STOMACH OPERATION ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON 03AUG2017: GASTRECTOMY. EVENT DESCRIPTION: AFTER USE 10 MM INSTRUMENT (SCOPE) AND STAPLER THE SEAL IS LEAKY WHEN THE SURGEON USE 5 MM INSTRUMENTS (GRASPER, SCISSOR OR DISSECTOR) THE LOSS OF PNEUMO WAS GRADUAL. THE SURGEON USING THE SCOPE NOT DIFFERENTLY THAN USUAL. THE HOSPITAL HAS EXPERIENCED SIMILAR ISSUES LAST YEAR. AME FOLLOWING UP WITH TM TO SEE IF ADDITIONAL CERS NEED TO BE CREATED ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON 03AUG2017: THERE WERE 6 SEALS USED DURING THIS PROCEDURE. LEAKAGE OCCURRED WITH EACH SEAL. ADDITIONAL CERS CREATED (6 TOTAL: (B)(6)). PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6927414 ↗
• MalfunctionOct 7, 2017Gas/Air Leak; Gas/Air Leak

  PROCEDURE PERFORMED: STOMACH OPERATION; ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON 03AUG2017: GASTRECTOMY. EVENT DESCRIPTION: AFTER USE10MM INSTRUMENT (SCOPE) AND STAPLER, THE SEAL IS LEAKY WHEN THE CHIRURGE USE 5MM INSTRUMENTS (GRASPER, SCISSOR OR DISSECTOR). THE LOSS OF PNEUMO WAS GRADUAL. THE SURGEON USING THE SCOPE NOT DIFFERENTLY THAN USUAL. THE HOSPITAL HAS EXPERIENCED SIMILAR ISSUES LAST YEAR. AME FOLLOWING UP WITH TM TO SEE IF ADDITIONAL CERS NEED TO BE CREATED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON 03AUG2017: THERE WERE 6 SEALS USED DURING THIS PROCEDURE. LEAKAGE OCCURRED WITH EACH SEAL. ADDITIONAL CERS CREATED (6 TOTAL: 2017-1496 + 2017-1514 + 2017-1515 + 2017-1516 + 2017-1517 + 2017-1518) TYPE OF INTERVENTION: N/A. PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6927395 ↗
• MalfunctionOct 7, 2017Gas/Air Leak; Gas/Air Leak

  PROCEDURE PERFORMED: STOMACH OPERATION ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON 03AUG2017: GASTRECTOMY. EVENT DESCRIPTION: AFTER USE 10MM INSTRUMENT (SCOPE) AND STAPLER THE SEAL IS LEAKY WHEN THE CHIRURGE USE 5MM INSTRUMENTS (GRASPER, SCISSOR OR DISSECTOR) THE LOSS OF PNEUMO WAS GRADUAL. THE SURGEON USING THE SCOPE NOT DIFFERENTLY THAN USUAL. THE HOSPITAL HAS EXPERIENCED SIMILAR ISSUES LAST YEAR. AME FOLLOWING UP WITH TM TO SEE IF ADDITIONAL CERS NEED TO BE CREATED ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON 03AUG2017: THERE WERE 6 SEALS USED DURING THIS PROCEDURE. LEAKAGE OCCURRED WITH EACH SEAL. ADDITIONAL CERS CREATED ((B)(4)) TYPE OF INTERVENTION: N/A. PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6927390 ↗
• MalfunctionOct 7, 2017Gas/Air Leak; Gas/Air Leak

  PROCEDURE PERFORMED: STOMACH OPERATION ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON 03AUG2017: GASTRECTOMY. EVENT DESCRIPTION: AFTER USE 10MM INSTRUMENT (SCOPE) AND STAPLER THE SEAL IS LEAKY WHEN THE CHIRURGE USE 5MM INSTRUMENTS (GRASPER, SCISSOR OR DISSECTOR) THE LOSS OF PNEUMO WAS GRADUAL. THE SURGEON USING THE SCOPE NOT DIFFERENTLY THAN USUAL. THE HOSPITAL HAS EXPERIENCED SIMILAR ISSUES LAST YEAR. AME FOLLOWING UP WITH TM TO SEE IF ADDITIONAL CERS NEED TO BE CREATED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON 03AUG2017: THERE WERE 6 SEALS USED DURING THIS PROCEDURE. LEAKAGE OCCURRED WITH EACH SEAL. ADDITIONAL CERS CREATED ((B)(4)). TYPE OF INTERVENTION: N/A. PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6927349 ↗
• MalfunctionJun 6, 2017Material Fragmentation; Material Fragmentation

  DXL LAP ECTOPIC - RUBBER VALVE BROKE AND A PIECE FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED. TYPE OF INTERVENTION - AN ADDITIONAL SEAL WAS USED. PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6616243 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED UNKNOWN. "BLACK RUBBER FROM INSIDE 12MM TROCAR BROKE OFF INSIDE PATIENT, THE PIECE WAS RETRIEVED BY SURGEON WITH NO APPARENT HARM TO THE PATIENT. NOTE: THIS IS THE SECOND OCCURRENCE FROM THE SAME LOT#. (PREVIOUS INCIDENT LINKED TO APPLIED (B)(4))." PATIENT STATUS: NO APPARENT PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372197 ↗
• MalfunctionMar 1, 2017Physical Resistance; Physical Resistance

  PROCEDURE PERFORMED UNKNOWN - "THE RESISTANCE SEEMS TO BE VERY HIGH WHEN INSERTING INSTRUMENTS THROUGH THE SEAL AND WHEN PULLING THEM BACK OUT. " PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370908 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC APPENDECTOMY - "CENTER PIECE OF TROCAR SEAL (BLACK SPONGE) BROKE OFF INTO THE PATIENTS ABDOMEN DURING LAPAROSCOPIC APPENDECTOMY. CENTER PIECE WAS RETRIEVED AND TROCAR WITH ALL PIECES HAVE BEEN KEPT FOR ROOT CAUSE ANALYSIS - NO APPARENT PATIENT HARM." PATIENT STATUS - "NO ADVERSE OUTCOMES REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370825 ↗
• MalfunctionFeb 7, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE NOT PROVIDED - "DISPOSABLE PREMIUM TROCAR SYSTEM UNIVERSAL (12 MM DISPOSABLE SEAL WITH STOPCOCK) BROKE (BLACK RUBBER PIECE CAME OUT OF CENTER) WHEN SURGEON ATTEMPTED TO PUT TROCAR THROUGH AND PULL IT OUT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM DISTRIBUTOR ON JANUARY 18, 2017 - IT WAS BELIEVED THAT THE RUBBER SEAL DETACHED WHEN THE OBTURATOR WAS FIRST PUT THROUGH THE CANNULA, AS THE SURGEON ATTEMPTED TO USE THE APPARATUS AND DEEMED IT NOT FUNCTIONING. THE SURGEON THEN REMOVED THE APPARATUS FROM THE PATIENT AND WHEN EXAMINING IT FOR WHY IT WAS NOT WORKING, REMOVED THE OBTURATOR FROM THE CANNULA, AND IT WAS OBVIOUS THE RUBBER SEAL WAS DETACHED/BROKEN. THE SEAL DID NOT FALL INTO THE PATIENT AS FAR AS THE DISTRIBUTOR KNOWS. PATIENT STATUS - "NO ADVERSE PATIENT EVENT/PATIENT HARM REPORTED".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6309613 ↗
• MalfunctionDec 30, 2016Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC CHOLECYSTECTOMY- "EVENT DESC: THIS WAS A LAPAROSCOPIC CHOLECYSTECTOMY CASE. THE DOCTOR FOUND OUT THE UNIVERSAL SEAL - A PIECE OF DISPOSABLE PART THAT GOES IN WITH THE (B)(6) - CAME OUT WITH A TEAR AND MISSING RUBBER PART." "WHAT WAS THE ORIGINAL INTENDED PROCEDURE- LAPAROSCOPIC CHOLECYSTECTOMY. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)" ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM USER FACILITY ON (B)(6) 2016: IT IS UNKNOWN WHAT INSTRUMENTS WERE BEING USED AT THE TIME OF THE EVENT. NO PIECES OF THE SEAL FELL INTO THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6216607 ↗
• MalfunctionNov 14, 2016Physical Resistance; Physical Resistance

  PROCEDURE PERFORMED UNKNOWN. "INSTRUMENT CATCHING INSIDE OF SEAL. NO ADVERSE EVENT/PATIENT HARM REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6099696 ↗
• MalfunctionNov 11, 2016Physical Resistance; Physical Resistance

  PROCEDURE PERFORMED: UNKNOWN -"INSTRUMENT CATCHING INSIDE OF SEAL. NO ADVERSE EVENT/PATIENT HARM REPORTED. EVENT SAMPLE AVAILABLE BUT IS CONTAMINATED. PLEASE ADVISE IF THE SAMPLE CAN BE SHIPPED DIRECT FROM CUSTOMER ((B)(6)) TO APPLIED MEDICAL. (B)(4) CANNOT ACCEPT CONTAMINATED PRODUCT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6097744 ↗
• MalfunctionJul 26, 2016Physical Resistance; Physical Resistance

  PROCEDURE PERFORMED: UNKNOWN - "INSTRUMENT CATCHING INSIDE OF SEAL. NO ADVERSE EVENT/PATIENT HARM REPORTED. EVENT SAMPLE AVAILABLE BUT IS CONTAMINATED. PLEASE ADVISE IF THE SAMPLE CAN BE SHIPPED DIRECT FROM CUSTOMER ((B)(6)) TO APPLIED MEDICAL. (B)(4). CANNOT ACCEPT CONTAMINATED PRODUCT." TYPE OF INTERVENTION: "N/A." PATIENT STATUS: "NO ADVERSE/PATIENT HARM REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5823464 ↗