Direct Drive® Clip Applier CA090Recalls & reported problems

Summary

The FDA's MAUDE database contains 806 adverse event reports that list this exact device (DI 00607915117306), received between Jan 25, 2016 and Mar 21, 2017 — classified as 1 death, 805 malfunctions.

The most frequently reported specific device problem is “Misfire” (393 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 25 most recent of 806 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2017Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED UNKNOWN - "AFTER OPENING THE PACKAGING, DEVICE WAS FOUND UNUSABLE. JAW WAS BLOCKED." PATIENT STATUS - "NA."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6423158 ↗
• MalfunctionMar 20, 2017Failure To Adhere Or Bond; Misfire; Failure To Adhere Or Bond; Misfire

  PATIENT PROCEDURE UNKNOWN- "USER REPORTED THAT ONE CLIP IS FIRED EVERY 3 TO 4 ACTUATION. DEVICE NEEDS TO BE ACTUATED 2 TO 3 TIMES IN ORDER TO CORRECTLY FIRE CLIP." PATIENT STATUS: OK.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6419307 ↗
• MalfunctionMar 10, 2017Failure To Adhere Or Bond; Misfire; Failure To Adhere Or Bond; Misfire

  LAP CHOLE- "4 EVENTS REPORTED WITH 4 DIFFERENT CLIP APPL, 2 DIFFERENT LOTS. NOT REPORTED SPECIFIC MALFUNCTION ASSOCIATED TO PROD. LOTS REPORTED ARE 1213391 AND 1213264 ( PLEASE REFER TO CER PORRETTA 3,4). THE SURG REPORTED NO FIRING OF CLIP AND NO COMPLETE CLOSURE/ WRONG CLOSURE OF THE CLIP AFTER FIRING. INTERVENTION WAS COMPLETED WITH A DIFFERENT BLAND CLIP APPLIER. NOT POSSIBLE TO RETIRE THE SAMPLES FOR INSPECTION BECAUSE THE EVENT WAS REPORTED TO ITALIAN MINISTRY OF HEALTH, SO PRODUCTS HAVE TO REMAIN AVAILABLE FOR MINISTRY EXAMINATION." PATIENT STATUS: GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6395597 ↗
• MalfunctionMar 9, 2017Misfire; Misfire

  PROCEDURE PERFORMED UNKNOWN. "NO CLIPS WERE OBSERVED DURING USE OF THE DEVICE. A SECOND DEVICE NEEDED TO BE USED." PATIENT STATUS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6391470 ↗
• MalfunctionMar 9, 2017Misfire; Misfire

  LAPAROSCOPIC CHOLECYSTECTOMY - "THE CLIP APPLIER ONLY FIRED THREE CLIPS AND NO CLIPS WOULD LOAD OR FIRE AFTER THE THIRD CLIP." PATIENT STATUS - "INCIDENT HAD NO AFFECT ON PATIENT. "

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6391443 ↗
• MalfunctionMar 9, 2017Misfire; Misfire

  LAPAROSCOPIC CHOLECYSTECTOMY - "ONLY 4 CLIPS CAME OUT OF THE CLIP APPLIER, AFTER WHICH THE CLIP APPLIER SEEMS TO BE EMPTY OF CLIPS." INTERVENTION - "X." PATIENT STATUS - "OK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6391441 ↗
• MalfunctionMar 9, 2017Misfire; Misfire

  PROCEDURE PERFORMED UNKNOWN - "DURING USE OF THE DEVICE IT WAS OBSERVED THAT IT CONTAINED 2 CLIPS INSTEAD OF 20. A SECOND DEVICE WAS USED." PATIENT STATUS - "OK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6391440 ↗
• MalfunctionMar 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  LAP CHOLE - "THE STAFF OPENED A CLIP APPLIER AND ATTEMPTED TO USE IT IN THE PATIENT, IT ONLY HAD THREE CLIPS IN IT WHICH WERE ATTEMPTED TO BE USED IN THE PATIENT. UPON QUERY TO THE STAFF NURSE MICHAEL INFORMS THAT THEY NEEDED TO OPEN ANOTHER DEVICE IN ORDER TO FINISH THE PROCEDURE." PATIENT STATUS - UNKNOWN, PATIENT STATUS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6391436 ↗
• MalfunctionMar 9, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  LAP CHOLE - "INST WERE CRACKED ON SIDE, IT SEEMED LIKE INST SPREAD APART AND DID NOT STAPLE CORRECTLY. I HAVE I INST HERE HAVE NOT SENT BACK YET." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6391429 ↗
• MalfunctionMar 8, 2017Misfire; Misfire

  PROCEDURE PERFORMED UNKNOWN. "STAPLES DOES NOT LOAD PROPERLY." PATIENT STATUS- FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6390204 ↗
• MalfunctionMar 8, 2017Mechanical Jam; Mechanical Jam

  N/A- "THIS CLIP WAS NOT USED ON CASE. PRIOR TO CASE SURGICAL TECH TRIED TO FIRE THE CLIP APPLIER. IT JAMMED SEVERAL CLIPS IN THE JAW OF THE INSTRUMENT." PATIENT STATUS - UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6390195 ↗
• MalfunctionMar 8, 2017Failure to Form Staple; Mechanical Jam; Failure to Form Staple; Mechanical Jam

  "HESITATION UPON FIRING, CLIP DID NOT FIRE." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6390187 ↗
• MalfunctionMar 8, 2017Misfire; Misfire

  LAP CHOLE - "ORIGINAL CUSTOMER DESCRIPTION: "TIP GOES IN WRONG DIRECTION" I REVIEWED THE CLIP APPLIER WHEN I PICKED IT UP ON TUESDAY JULY 8 AND A CLIP APPEARED AS THOUGHT IT FED SIDEWAYS, BUT AFTER FIRING IT ONCE TO SEE WHAT WAS MEANT BY "TIP GOES IN WRONG DIRECTION" THE CLIP FIRED NORMALLY. I WORKED TO GET ADDITIONAL INFORMATION FROM THE CUSTOMER ON THE DESCRIPTION AND WAS UNSUCCESSFUL." PATIENT STATUS - "OK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6390182 ↗
• MalfunctionMar 8, 2017Mechanical Jam; Mechanical Jam

  LAP ROUXEN-Y- "THE CLIP APPLIER HAD NO BLUE CLIPS AT THE END OF THE CLIP APPLIER AND IT NEVER LOCKED UP. THE AMOUNT OF CLIPS THAT WERE USED IS UNKNOWN." PATIENT STATUS - "NORMAL".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6390176 ↗
• MalfunctionMar 7, 2017Misfire; Misfire

  LAP CHOLE- "FIRED FIRST AND SECOND CLIP THEY WERE FINE. THE THIRD CLIP FELL OUT OF THE CLIP APPLIER. THE 4TH 5TH AND 6TH CLIP ALSO FELL OUT OF THE CLIP APPLIER. THE NEXT CLIP APPLIER WAS FINE. CASE #2 AND 3, THE CLIPS WERE BOTH FINE. THE FOURTH CASE, THE THIRD CLIP FIRED FELL OUT OF THE CLIP APPLIER ALSO. ALL OF THE CLIP APPLIERS WERE DISCARDED AND UNRECOVERABLE." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6385902 ↗
• MalfunctionMar 7, 2017Misfire; Misfire

  LAP CHOLE- "FIRED FIRST AND SECOND CLIP THEY WERE FINE. THE THIRD CLIP FELL OUT OF THE CLIP APPLIER. THE FOURTH, FIFTH AND SIXTH CLIP ALSO FELL OUT OF THE CLIP APPLIER. THE NEXT CLIP APPLIER WAS FINE. CASE #2 AND 3, THE CLIPS WERE BOTH FINE. THE FOURTH CASE, THE THIRD CLIP FIRED FELL OUT OF THE CLIP APPLIER ALSO. ALL OF THE CLIP APPLIERS WERE DISCARDED AND UNRECOVERABLE." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6385901 ↗
• MalfunctionMar 2, 2017Misfire; Misfire

  LAPAROSCOPIC CHOLECYSTECTOMY - "LOADED APPLIER PRIOR TO USE, MISFIRED, SECOND ATTEMPT 2 STAPLE FIRED RELOADED MISFIRED AGAIN X5 REMOVED FROM FIELD, REPLACED WITH NEW ONE. DR. (B)(6) WAS PHYSICIAN. NURSE REPORTED, (B)(6)." PATIENT STATUS: POSSIBLE BLEEDING.

  Patient problems: No Code Available

  MAUDE report 6375126 ↗
• MalfunctionMar 2, 2017Failure to Form Staple; Failure to Form Staple

  PROCEDURE PERFORMED UNKNOWN- "DURING USE OF THE DEVICE CLIPS GOT CROSSED- RISK OF BLEEDING." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6375125 ↗
• MalfunctionMar 2, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  LAPAROSCOPIC GASTRIC BANDING- "WOULD NOT CLOSE COMPLETELY ON 5 CLIPS." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6374955 ↗
• MalfunctionMar 2, 2017Unintended Ejection; Unintended Ejection

  LAP CHOLE - "THE DEVICE SPIT SEVERAL CLIPS WITHOUT PROPERLY FORMING ANY." PATIENT STATUS - "PATIENT DID WELL."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6373617 ↗
• MalfunctionMar 2, 2017Misfire; Misfire

  "THIS IS A COMPLAINT FROM THE MARKET. (B)(4). THE DEFECT UNIT WITHOUT CLIPS WILL BE RETURNED TO AMR. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." COMPLAINT SHEET- "THE THIRD CLIP WOULD NOT BE LOADED, CAUSING THE CLIP APPLIER TO BE UNUSABLE. THE PHYSICIAN, WHO IS SKILLFUL WITH THE DEVICE, COULD NOT PROCEED WITH THE PROCEDURE AND WOULD LIKE TO KNOW WHY THE INCIDENT HAPPENED. THE FIRST AND SECOND CLIP HAD NO TROUBLE WITH CLIPPING. THE EVEN UNIT WITHOUT CLIPS WAS RETURNED TO OLYMPUS AND VISUALLY INSPECTED : NO VISIBLE DAMAGE WAS FOUND WITH THE UNIT. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. (B)(4)." PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6373616 ↗
• MalfunctionMar 2, 2017Mechanical Jam; Mechanical Jam

  LAP CHOLE- "ONLY 3 CLIPS WERE AVAILABLE TO USE BEFORE IT LOCKED UP." PATIENT STATUS- "OK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6373614 ↗
• MalfunctionMar 2, 2017Failure to Form Staple; Failure to Form Staple

  LAPAROSCOPIC: "SURGEON WENT TO USE CLIP APPLIER BUT SAYS IT FAILED, NO OTHER DESCRIPTION GIVEN AT THE TIME." PATIENT STATUS: OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6373613 ↗
• MalfunctionMar 2, 2017Failure to Form Staple; Failure to Form Staple

  "SURGEON WENT TO USE CLIP APPLIER BUT SAYS IT FAILED, NO OTHER DESCRIPTION GIVEN AT THE TIME." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6373612 ↗
• MalfunctionMar 2, 2017Unintended Ejection; Misfire; Unintended Ejection; Misfire

  LAPAROSCOPIC CHOLE CYSTECTOMY- "WHEN PHYSICIAN TRIGGER TO APPLY CLIP, MULTIPLE CLIPS CAME OUT. PHYSICIAN STATES APPLIER "EXPLODED" WHEN MULTIPLE CLIPS CAME OUT AT ONCE." PATIENT STATUS- "PATIENT IS OK, NO HARM DONE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6373610 ↗