Direct Drive Reposable Graspers C4120Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00607915116866), received between Sep 7, 2016 and Jul 16, 2026 — classified as 4 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841455 ↗
• MalfunctionAug 26, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAVH EVENT DESCRIPTION: A PIECE OF THE GRASPER FELL OUTSIDE OF THE PATIENT. THE DEVICE WAS NOT ABLE TO GRASP. THE PIECE THAT FELL WAS ACCOUNTED FOR DURING THE PROCEDURE. THEY WERE TRYING TO GRASP UTERINE TISSUE. ADDITIONAL INFORMATION OBTAINED FROM HOSPITAL REPRESENTATIVE VIA EMAIL ON (B)(6) 2025: THE GRASPER WAS BEING USED TO GRASP THE UTERUS AND THE HINGE BECAME LOOSE. NOTHING BROKE OFF OR FELL INTO THE PATIENT; THE DEVICE JUST WOULD NOT GRASP. IT WAS REMOVED FROM THE PATIENT AND OFF THE FIELD WITH ALL PIECES INTACT. WHEN INSPECTING OFF THE FIELD, A PIECE FELL OUT FROM THE HINGE AREA. IT IS NOT VISIBLE IN THE PICTURE. IT IS MORE OF A PIECE OF METAL THAT FELL FROM THE INSIDE OF THE HINGE WHILE WE WERE INSPECTING IT. INTERVENTION: THE GRASPER WAS REMOVED FROM THE FIELD AND A NEW GRASPER WAS OPENED. PATIENT STATUS: NO ADVERSE EVENT OR INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898298 ↗
• MalfunctionAug 21, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: GRASPER WAS WORKING FINE WHEN TAKEN OUT OF PACKAGE. PRODUCT BROKE INSIDE PATIENT DURING OPERATION. HSS HAS RECEIVED A PRODUCT COMPLAINT FROM [HOSPITAL], SEE PRODUCT DETAIL BELOW: PRODUCT: DIRECT DRIVE REPOSABLE GRASPERS SUPPLIER PART NUMBER: N/A. BATCH: 1545993. SUPPLIER: APPLIED MEDICAL. COMPLAINT: ["DAMAGED/REQUIRES REPAIR OR REPLACEMENT". DESCRIPTION: GRASPER WAS WORKING FINE WHEN TAKEN OUT OF PACKAGING. PRODUCT BROKE INSIDE PATIENT DURING THE OPERATION. ACTION: PRODUCT WAS ASSESSED TO SEE IF ANY PARTS WERE POSSIBLY WITHIN THE PATIENT CAVITY. A NEW GRASPER WAS OPENED. IS PRODUCT AVAILABLE? YES. IS PACKAGING AVAILABLE? YES. CAN YOU PLEASE LIAISE DIRECTLY WITH THE COMPLAINANT TO ARRANGE PICK UP OF THE FAULTY ITEM/S. WE REQUEST THAT A WRITTEN CORRECTIVE ACTION PLAN IS PROVIDED, CLEARLY DEFINING A PLANNED SOLUTION AND A TIMEFRAME BY THE KPI DEADLINE OF 21 AUGUST 2025. NO CLINICAL IMPACT. ADDITIONAL INFO RECEIVED BY AMR REP VIA EMAIL ON AUGUST 18, 2025: 1. WHAT COMPONENT OF THE DEVICE BROKE? HINGE BROKE AND CAME LOOSE ON THE NECK OF GRASPER. 2. WHAT CIRCUMSTANCES THAT LED TO THE BREAK? THE CIRCUMSTANCES LEADING TO THE INCIDENT WAS THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868967 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP BSO. EVENT DESCRIPTION: PRIOR TO REPORTING, INTERNAL HOSPITAL DOCUMENT FILLED BY NURSE STATES: BLUE GRASPER TIP CAME OFF IN PATIENT DURING LAPAROSCOPIC SALPINGO-OOPHERECTOMY AND WAS LUCKILY SEEN AND FOUND IMMEDIATELY. FROM PCF ON 25JUN2025: GRASPER WAS BEING USED AS PER USUAL, AND THE OPERATING TEAM NOTICED THE BLUE "LATIS" PAD HAD FALLEN OFF THE GRASPER TIPS. ADDITIONAL INFORMATION WAS PROVIDED BY [NAME], AMA TERRITORY MANAGER VIA EMAIL ON 26-JUN-2025. THE LOT NUMBER OF THE COMPLAINT DEVICE WAS CONFIRMED AS 1538058. THE TERRITORY MANAGER BELIEVES IT WOULD HAVE BEEN ORDERED FROM [LOCATION]. INTERVENTION: DEVICE WAS REPLACED. PATIENT STATUS: UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384425 ↗
• MalfunctionFeb 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: HIATUS HERNIA REPAIR. EVENT DESCRIPTION: GRASPING TISSUE AND BOWEL DURING HIATUS HERNIA REPAIR, NO DIFFERENT TO ANY OTHER CASE. SURGEON REGULARLY USES 2X ATRAX GRASPERS IN EVERY HIATUS HERNIA REPAIR AND HAS NEVER HAD AN ISSUE. SURGEON MOVED THE CAMERA AND NOTICED THAT THE GRASPER WAS NOT GRASPING AS USUAL. WHEN HE MOVED THE CAMERA, HE NOTICED THE BLUE LATIS PAD IN THE CORNER OF THE SCREEN. UPON CHECKING THE GRASPER, THE PAD HAD FALLEN OFF AND INTO THE PATIENT'S ABDOMINAL CAVITY, OF WHICH HE RETRIEVED. THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT AS LATIS PAD WAS FOUND AND RETRIEVED FROM PATIENT. SURGEON RETRIEVED LATIS PAD FROM PATIENT AND REPORTED VIA HOSPITAL REPORTING (RISK MAN) AND ADVISED ALL RELEVANT PERSONNEL AS PER HOSPITAL POLICY. INTERVENTION: LATIS PAD FROM GRASPER DETACHED FROM MAIN SHAFT AND WAS REMOVED BY SURGEON. PATIENT STATUS: STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318216 ↗
• MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: COMPLAINT CREATED FROM MEDWATCH, MDR REPORT # MW5160650. THIS IS AN ANONYMOUS COMPLAINT FILED BY AN UNKNOWN REPORTER VIA MEDWATCH. THUS, NO FURTHER INFORMATION CAN BE OBTAINED. DURING SURGERY, THE GRASPER TIP WAS COMING OFF OF THE INSTRUMENT AND NOTICED. REMOVED FROM PATIENT AND DETERMINED ALL WAS STILL INTACT AND OUT OF THE PATIENT DURING REMOVAL AND AFTER REMOVAL. INSTRUMENT REMOVED FROM THE STERILE FIELD. INTERVENTION: REMOVED FALLEN GRASPER TIP FROM PATIENT. PATIENT STATUS: NI.

  Patient problems: Insufficient Information

  MAUDE report 20763695 ↗
• InjuryNov 15, 2024Sharp Edges; Sharp Edges

  NAME OF PROCEDURE BEING PERFORMED: ROBOTIC ASSISTED RIGHT HEMICOLECTOMY DESCRIPTION OF EVENT: [HOSPITAL] EVENT DATE: 18 SEP 2024 MODEL #: C4120 LOT #: 1519144 THE PROCEDURE WAS A ROBOTICS-ASSISTED RIGHT HEMICOLECTOMY. THE TIP OF THE GRASPER INJURED THE BOWEL WALL. THE DEVICE WAS USED FOR TWO MINUTES. THE PHYSICIAN DID NOT OPEN ANOTHER DEVICE. PATIENT STATUS: NI TYPE OF INTERVENTION: NI

  Patient problems: Insufficient Information

  MAUDE report 20700570 ↗
• MalfunctionSep 27, 2024Material Separation; Material Separation

  PROCEDURE PERFORMED: ROBOTIC LEFT PARTIAL NEPHRECTOMY. EVENT DESCRIPTION: THE DEVICE WAS USED AS INDICATED. GRASPER BLUE RUBBER TIP WAS BREAKING AWAY DETACHING FROM TIP OF GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, NO PATIENT INCIDENT WAS RECORDED. TYPE OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT INCIDENT RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323813 ↗
• MalfunctionAug 22, 2024Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAPAROSCOPIC CYSTECTOMY EVENT DESCRIPTION: THE HANDLE WAS ATTEMPTING TO BE OPENED BUT THE JAWS WERE NOT MOVING. THE REPOSABLE GRASPER WAS BEING SCREWED ON NORMALLY AND THEN FAILED TO OPEN AND OPERATE. REP WAS PRESENT IN THE THEATRE. ANOTHER HANDLE WAS OPENED AND WAS SCREWED ONTO THE DIRECT DRIVE GRASPER AND AGAIN IT WOULDN'T WORK. CLINICAL IMPACT: NO, IT DID NOT GO NEAR THE PATIENT. (B)(6) 2024 RECEIVED CLARIFICATION THAT THE C4120 WAS TRIED ON A SECOND HANDLE TO DETERMINE WHAT WAS FAULTY AND IT TURNED OUT TO BE THE C4120. THERE IS ONLY ONE FAULTY DEVICE AND ONLY ONE DEVICE TO BE RETURNED. INTERVENTION: ANOTHER FORM OF GRASPER WAS USED. PATIENT STATUS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036558 ↗
• MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: SMALL BOWEL RESECTION EVENT DESCRIPTION: DR [NAME] WAS PERFORMING SMALL BOWEL RESECTION. THE PADDED ENDS CAME OFF WHEN USING THE INSERTS FOR THE LAPAROSCOPIC CASE. THE SURGEON HAD USED THIS DEVICE MANY TIMES PRIOR TO THIS EVENT. THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. ANOTHER DEVICE WAS USED TO RESOLVE THE SITUATION. PATIENT STATUS: WHEN USING THE INSERTS THE PADDED ENDS CAME OFF AND CAUSED MINOR TRAUMA TO THE BOWEL. PATIENT IS UNHARMED AND DID NOT CHANGE TO PROCEDURE PERFORMED IN ANY WAY. INTERVENTION: USED ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19233364 ↗
• InjuryAug 21, 2023Material Frayed; Material Frayed

  PROCEDURE PERFORMED: LAPARASCOPIC RIGHT HEMICOLECTOMY. EVENT DESCRIPTION: THE SMALL BOWEL WAS BEING GRASPED DURING HEMICOLECTOMY WHEN THE EVENT OCCURRED. MESSAGE FROM CNS: [NAME] PERFORMING LAP RIGHT HEMI; "YESTERDAY WE HAD A FAULTY GRASPER (C4120 ¿ LOT:1465118). IT HAD A PIECE OF THE MESH MATERIAL STICKING OUT AND IT MADE A SMALL HOLE IN THE SMALL BOWEL. THE GRASPER WASN¿T CHECKED PRIOR TO USE BUT WAS NOTICED AS THE SURGEON GRABBED THE BOWEL WITH THE GRASPER AND A HOLE FORMED." THE SMALL BOWEL WAS PUNCTURED. IT WAS SUBSEQUENTLY REPAIRED. DEVICE REPLACED WITH ANOTHER C4120. ADDITIONAL INFORMATION RECEIVED FROM [NAME] VIA EMAIL ON (B)(6) 2023. SMALL BOWEL WAS REPAIRED BY SUTURING. BLEEDING AND SMALL BOWEL DAMAGE. INTERVENTION: SMALL BOWEL WAS REPAIRED BY SUTURING. DEVICE REPLACED WITH ANOTHER C4120. PATIENT STATUS: SMALL BOWEL WAS REPAIRED AND PATIENT IS STABLE.

  Patient problems: Bowel Perforation

  MAUDE report 17588611 ↗
• MalfunctionMar 22, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP HERNIA REPAIR EVENT DESCRIPTION: THE LATTICE PAD POPPED OFF ONE OF THE JAWS DURING SURGERY. THE PAD WAS RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH A NEW DEVICE. NO PATIENT INJURY AND THE PATIENT IS DOING FINE. PRODUCT AVAILABLE FOR RETURN. INTERVENTION: USED A NEW ONE TO COMPLETE THE CASE PATIENT STATUS: FINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593165 ↗
• InjuryMay 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE PERFORMED: COLON RESECTION. EVENT DESCRIPTION: DURING THE CASE THE SURGEON WAS USING THE DEVICE TO GRASP BOWEL AND MESENTERY. BLEEDING WAS NOTED ON THESE TISSUES. THE GRASPER WAS THE ONLY DEVICE USED TO GRAB BOWEL DURING THE CASE. IT IS UNKNOWN HOW THE BLEEDING WAS ADDRESSED DURING THIS PROCEDURE. THE CASE WAS COMPLETED BUT TWO DAYS LATER THE PATIENT HAD TO HAVE A SECOND OPERATION. IT IS UNKNOWN WHAT WAS THE REASON FOR THE SECOND PROCEDURE AND IF THE DEVICE CONTRIBUTED TO THE NEED FOR THIS SECOND OPERATION. DURING THE SECOND PROCEDURE IT WAS NOTED THAT THERE WAS BLEEDING ON THE SMALL BOWEL. IT IS UNKNOWN HOW THE BLEEDING WAS ADDRESSED DURING THIS SECOND PROCEDURE. THE CASE WAS COMPLETED AND THE PATIENT IS CURRENTLY IN THE HOSPITAL. PATIENT STATUS IS OKAY. PRODUCT IS NOT AVAILABLE FOR RETURN. THE PRODUCT WAS DISPOSED OF AFTER THE FIRST CASE. ADDITIONAL INFORMATION RECEIVED BY EMAIL ON (B)(6) 2022 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER I: THE FIRST CASE WAS ON (B)(6) 2022 AND THE SECOND PROCEDURE WAS ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED BY PHONE ON (B)(6) 2022 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER I: THE REP SPOKE WITH THE SURGEON ABOUT THE CASE AND

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14414683 ↗
• MalfunctionAug 26, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NAME OF PROCEDURE BEING PERFORMED: NI. DETAILED DESCRIPTION OF EVENT: BEFORE THE CASE WAS STARTED THE SURGICAL TEAM OPENED THE PACKAGING OF THE PRODUCT AND NOTICED A SMALL HOLE IN THE STERILE PACKAGING. THE PRODUCT WAS NOT USED IN PATIENT TREATMENT AND A NEW GRASPER WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 13AUG2021 VIA EMAIL FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER III: PHOTOS OF THE PRODUCT HAVE BEEN PROVIDED. THE LOT NUMBER IS 1419762. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 10SEP2021 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER III: HOSPITAL LOST THE DEVICE, PRODUCT NOT RETURNING. PATIENT STATUS: NO PATIENT CONTACT. TYPE OF INTERVENTION: USED A NEW GRASPER TO COMPLETE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375375 ↗
• MalfunctionMar 12, 2021Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LOWER ANTERIOR COLON RESECTION. THE ACCOUNT MGR WAS PRESENT FOR THE CASE. [NAME] WAS PERFORMING A LOWER ANTERIOR COLON RESECTION. THE GRASPER WAS BEING USED WITH THE CTF03 TROCAR. HE NOTICED THAT THE JAWS OF THE GRASPER WERE MISALIGNED. HE WAS NOT GRABBING TISSUE AT THE TIME AND HAD ALREADY PLACED THE DRAIN IN THE PATIENT. HE STATED THAT HE DID NOT RECOLLECT WHEN OR HOW THE JAW BECAME MISALIGNED. A NEW GRASPER WAS OPENED AND THE CASE WAS COMPLETED. THERE WAS NO DAMAGE TO THE TISSUE. THERE WAS NO PATIENT INJURY. THERE ARE NO PHOTOS AVAILABLE. THE DEVICE IS AVAILABLE TO BE RETURNED. REPLACED WITH A NEW GRASPER. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478045 ↗
• MalfunctionNov 12, 2020Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: TLH GRASPER WOULD NOT RELEASE TISSUE AFTER HOLDING TISSUE BETWEEN JAWS THE CLINICIANS TRIED TO OPEN THE GRASPER BY REMOVING THE HANDLE AND THE JAWS STILL DIDN'T OPEN. THIS WAS ATTEMPTED 3 TIMES WITH AND WITHOUT THE HANDLE AND EVENTUALLY THE TISSUE WAS RELEASED WITH NO INJURY TO PATIENT. PATIENT STATUS: PATIENT IS FINE, AND COMPLETELY UNAFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10830324 ↗
• MalfunctionOct 23, 2020Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: NI. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM [NAME] 27.08.2020: I STILL DON¿T HAVE A DETAILED DESCRIPTION, BUT WAS TOLD BRIEFLY THAT THE JAWS COULDN¿T CLOSE AFTER OPENING INSIDE THE PATIENT, SO THE GRASPER COULDN¿T BE REMOVED VIA THE PORT, SO HAD TO REMOVE BOTH GRASPER AND PORT TOGETHER. WHEN I HEAR BACK I CAN ADD FURTHER COMMENT. INTERVENTION: NI. PATIENT STATUS: PATIENT IS FINE, AND COMPLETELY UNAFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10731132 ↗
• MalfunctionJul 20, 2020Mechanical Jam; Mechanical Jam

  NAME OF PROCEDURE: TOUPET FUNDOPLICATION. THE REP WAS PRESENT FOR THE CASE. SURGEON WAS USING 2 GRASPERS DURING THE CASE. THE HANDLE WAS STICKING AND NOT OPENING & CLOSING SMOOTHLY THROUGHOUT THE CASE. THE SURGEON WAS GRASPING THE STOMACH AND WENT TO RELEASE THE HANDLE. HE HAD A HARD TIME GETTING THE JAWS TO OPEN AND THEY WERE STUCK INSIDE THE TROCAR WITHIN THE ABDOMEN. HE KEPT MANIPULATING AND SQUEEZING THE HANDLE TO GET IT TO RELEASE AND REMOVE FROM THE TROCAR. ONCE THE GRASPER WAS REMOVED FROM THE TROCAR, THEY COULD NOT GET IT TO CLOSE. OPENED A C4130 GRASPER TO USE ALONGSIDE THE 2ND C4120 GRASPER BEING USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. THERE ARE NO PHOTOS AVAILABLE. THE DEVICE IS AVAILABLE TO BE RETURNED. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: OPENED ANOTHER GRASPER TO COMPLETE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10297896 ↗
• MalfunctionJul 1, 2020Break; Break

  PROCEDURE PERFORMED: PARAESOPHAGEAL HERNIA REPAIR. THE REP WAS NOT PRESENT FOR THE CASE. IN THE MIDDLE OF THE CASE, THE SURGEON WENT TO SQUEEZE THE HANDLE AND THE HINGE BROKE AND CAME OUT OF THE SHAFT. IT IS UNKNOWN WHAT TYPE OF TISSUE WAS BEING GRASPED WHEN THE BREAKAGE OCCURRED. A NEW GRASPER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE TO BE RETURNED. INTERVENTION: OPENED ANOTHER GRASPER TO COMPLETE CASE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10221510 ↗
• MalfunctionJul 3, 2019Mechanical Problem; Mechanical Problem

  PROCEDURE PERFORMED: NOT KNOWN. EXTREMELY LIMITED INFORMATION AVAILABLE. SURGEON USES THIS PRODUCT ROUTINELY AND DOES NOT HAVE ISSUES WITH IT. ON THIS OCCASION SURGEON COMMENCED USING GRASPER AND STATED THE JAWS WERE "TOO TIGHT" (DIFFICULT TO OPEN) AND CEASED USING. NO INFORMATION AVAILABLE AS TO WHEN JAWS BECAME TIGHT OR IF THEY WERE TIGHT FROM THE BEGINNING OF USE. REPOSABLE SHAFT WAS REPLACED WITH A NEW ONE AND CASE PROCEEDED AS USUAL. THE REUSEABLE HANDLE REMAINED THE SAME. PATIENT WAS NOT AFFECTED. NO INFORMATION ON OTHER INSTRUMENTS USED AT THE TIME OR WHAT PROCEDURE. PATIENT STATUS: PATIENT DID NOT INCUR INJURY. TYPE OF INTERVENTION: PRODUCT REPLACEMENT DURING CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8761164 ↗
• MalfunctionMay 30, 2019Mechanical Problem; Mechanical Problem

  PROCEDURE PERFORMED: UNK. MEDWATCH #0504240000-2019-8015 THE GRASPER JAWS WERE TIGHT, DID NOT OPEN AND CLOSE PROPERLY. THEY WERE TAKEN OFF THE FIELD AND REPLACED WITH NEW DEVICE WITHOUT EVENT. THERE WAS NO HARM TO THE PATIENT. DATE OF EVENT FEB 2019. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06MAY2019 FROM RISK MANAGEMENT COORDINATOR: DATE OF EVENT 2/11/19 SAME AS STATED ON MED WATCH REPORT. INFORMATION NOT PROVIDED FOR THE QUESTIONS AT WHAT POINT DURING THE PROCEDURE DID THE DEVICE BECOME DIFFICULT TO ACTUATE. INFORMATION NOT PROVIDED FOR THE QUESTION WAS IT DIFFICULT TO ACTUATE UPON INITIAL USE. PATIENT STATUS: THERE WAS NO HARM TO THE PATIENT. TYPE OF INTERVENTION: THEY WERE TAKEN OFF THE FIELD AND REPLACED WITH NEW DEVICE WITHOUT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8654483 ↗
• MalfunctionApr 12, 2019Material Deformation; Material Deformation

  PROCEDURE PERFORMED: LAP HIGH ANTERIOR RESECTION. THE BLUE INSERT BREAKING AWAY. MORE INFORMATION TO FOLLOW. ON (B)(6) 2018 - NO MORE INFORMATION ABOUT EVENT, OTHER THAN THE GEL PADS ON THE GRASPER JAWS COMING AWAY. THE LOT NO IS 1323560. PATIENT STATUS: PATIENT DID NOT OCCUR INJURY. TYPE OF INTERVENTION: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511700 ↗
• MalfunctionMar 6, 2019Mechanical Problem; Mechanical Problem

  PROCEDURE PERFORMED: ADHESIOLYSIS. DURING THE CASE THE SURGEON FOUND THE ATRAX TO BE VERY CLUNKY WHEN CLOSING AND OPENING THE JAW. THIS STICKING OR RIGIDITY WAS NOT THE REUSABLE HANDLE AS A SECOND ATRAX WAS OPENED AND THERE WAS NO ISSUE WITH THE SECOND ITEM PATIENT STATUS: PATIENT DID NOT INCUR INJURY. TYPE OF INTERVENTION: OPENED NEW PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8397327 ↗
• MalfunctionFeb 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ESOPHAGOSTOMY. LIMITED INFORMATION AVAILABLE AT THIS TIME. THE BLUE ATRAUMATIC PADS ARE FALLING OFF OF THE JAWS. THE PADS WERE RETRIEVED OUT OF THE PATIENT. THE ENTIRE PAD DETACHED FROM THE JAWS. DID NOT KNOW HOW THE GRASPER WAS BEING USED AT THE TIME OF THE INCIDENT. DID NOT KNOW HOW THE PROCEDURE WAS COMPLETED. PRODUCT WAS DISCARDED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2019 FROM ACCOUNT MANAGER: THE CASE WAS ON (B)(6) 2019. IT WAS AN ESOPHAGOSTOMY BY [DOCTOR]. IT WAS USED TO GRASP AND THE BLUE PADS CAME OFF THE GRASPER AND ONE OF THEM COULD NOT BE FOUND. THEY DID HAVE TO USE ANOTHER GRASPER. ADDITIONAL INFORMATION MW5083609 WAS RECEIVED VIA MAIL ON (B)(6) 2019 FROM THE FDA: MW5083609. EVENT DATE: (B)(6) 2019. C4120 LOT NUMBER 1340949. DEVICE NOT AVAILABLE FOR RETURN. EVENT DESCRIPTION: DURING A ROBOTIC ESOPHAGECTOMY WITH GASTRIC PULL-UP CASE, AN APPLIED MEDICAL GRASPER MALFUNCTIONED. THE TWO BLUE FABRIC PADS ON THE INSTRUMENT CAME OFF INTO THE PATIENT'S ABDOMEN. ONE PAD WAS EASILY FOUND. THE OTHER WAS EITHER FLUSHED OUT OR REMAINS (NON-RADIOPAQUE AND NOT VISIBLE ON X-RAY TAKEN). PATIENT STATUS: FINE. TYPE OF INTERVENTION: THEY DID HAVE TO USE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8380312 ↗
• MalfunctionJun 29, 2017Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: LAP LIVER RESECTION. INCIDENT DESCRIPTION: AS USING GRASPER IN SOME POINT IN THE MIDDLE OF THE CASE, ONE OF THE LATIS PADS FELL OFF. IT OCCURRED WHEN THEY WERE MOVING AND MANIPULATING TISSUE.. AS THE DOCTOR LOOKED AT THE JAWS, HE NOTICED THE PAD HAD FULLY DETACHED FROM THE JAWS. THEY WERE ABLE TO RETRIEVE THE PAD. THE PRODUCT WILL NOT BE RETURNING AS THE HOSPITAL DISPOSED THE PRODUCT. TYPE OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6679199 ↗