Direct Drive Reposable Graspers C4121Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00607915116873), received between Feb 29, 2016 and Jun 4, 2024 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC HEMICOLECTOMY. EVENT DESCRIPTION: EMAIL WAS RECEIVED BY [NAME], AMA REGIONAL SALES MANAGER ON 30-MAY-2024 REGARDING AN EVENT AT THE HOSPITAL FROM [NAME], NURSE UNIT MANAGER, CLINICAL CONSUMABLES GROUP AT [HOSPITAL]. A PRODUCT COMPLAINT WAS INTERNALLY RAISED AT THE HOSPITAL REGARDING C4120 DIRECT DRIVE REPOSABLE GRASPER THAT BROKE OFF INSIDE A PATIENT. IT WAS STATED THAT THE PRODUCT WAS NOT X-RAY DETECTABLE. NUM WANTED A CONFIRMATION IF THE PRODUCT PART WAS X-RAY DETECTABLE. RSM SPOKE TO THE CUSTOMER AND CONFIRMED THAT COMPLAINT WAS SUBMITTED INTERNALLY IN THE HOSPITAL AND DUE TO STAFF SHORTAGES, THE METRO NORTH PROCUREMENT MAY TAKE SOME TIME TO PROCESS THE COMPLAINT AND SUBMIT TO US. PER RSM'S DISCUSSION WITH NUM, IT APPEARS THAT IT WAS THE POLYCARBONATE BIT THAT WAS DETACHED. THE NUM CONFIRMED THAT THE PATIENT IS SAFE, HOWEVER ADDED THAT THE FOREIGN BODY MIGHT STILL BE IN THE PATIENT. PROCEDURE WAS ROBOTIC HEMICOLECTOMY - THE PAD POPPED OFF AS THEY WERE USING IT TO PUT A [SPONGE] INTO ABDOMEN. PATIENT STATUS: PATIENT IS SAFE. INTERVENTION: NI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464247 ↗
• MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC COLON RESECTION. EVENT DESCRIPTION: THE PAD FROM THE TIP OF THE GRASPER DETACHED AND FELL INTO THE PATIENT'S CAVITY. IT WAS REMOVED SUCCESSFULLY, AND THE CASE WAS COMPLETED. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 6MAR2024 VIA EMAIL: I AM STILL WAITING FOR ADDITIONAL INFORMATION ABOUT HOW THE GRASPERS WERE BEING USED AT THE TIME OF THE INCIDENT. HOWEVER, I DO KNOW THAT THERE ARE NOT ANY PHOTOS TAKEN. PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: THE PAD WAS REMOVED FROM THE PATIENT SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234610 ↗
• MalfunctionMar 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  TYPE OF PROCEDURE: NI. EVENT DESCRIPTION: HOSPITAL: [HOSPITAL]. PRODUCT: 45CM GRASPER. "ROBOTIC CASE. BLUE PADS (REPORTER ASSUMES BOTH BLUE PADS OF THE GRASPER) DETACHED AND FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE PADS." PRODUCTS AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. INTERVENTION: NI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895138 ↗
• MalfunctionJul 20, 2023Material Frayed; Material Separation; Material Frayed; Material Separation

  PROCEDURE PERFORMED: LAPAROSCOPIC ROUX-EN-Y. TWO SIMILAR COMPLAINTS OCCURRED AT [USER FACILITY]: COMPLAINT 1 OF 2: (B)(4) - C4121 LOT #1472638 [MFR #2027111-2023-00528] COMPLAINT 2 OF 2: (B)(4) [MFR #2027111-2023-00529]. THE SURGEON USED TWO GRASPERS DURING "SOFT LAUNCH TESTING" AND ONE OF THE DEVICES EXPERIENCED FRAYING AT THE TIP OF THE LATIS PAD. THE SURGEON NOTICED THAT THE LATIS PAD WAS FRAYING TWO HOURS INTO THE THREE-HOUR PROCEDURE. THE OTHER DEVICE DID NOT EXPERIENCE FRAYING OR ANY OTHER ISSUES. THEY WERE ABLE TO FINISH THE PROCEDURE NORMALLY. THERE WAS NO IMPACT TO THE CASE. NO PATIENT INJURY. THE SURGEON NOTED THAT THEY HAVE SEEN THIS ISSUE IN THE PAST BUT THE DEVICE ALWAYS PERFORMED AS NEEDED. BOTH DEVICES USED DURING THE PROCEDURE ARE RETURNING FOR COMPLAINT #(B)(4). [] ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 23JUN2023 FROM [NAME], CLINICAL DEVELOPMENT ANALYST II, APPLIED MEDICAL: NO, THE USER DID NOT EXPERIENCE ANY TISSUE STICKING OR TEARING WHEN USING THE FRAYED DEVICE. "THE GRASPERS WERE BEING USED TO HANDLE TISSUE DURING A BARIATRIC ROUX-EN-Y PROCEDURE. THESE TISSUES/ORGANS INTERACTED WITH INCLUDE THE STOMACH, SMALL INTESTINE, FAT TISSUE (OMENTUM AND VISCER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367904 ↗
• MalfunctionApr 30, 2021Separation Failure; Separation Failure

  PROCEDURE PERFORMED: ROBOT ASSIST PARAESOPHAGEAL HERNIA REPAIR W/MESH. LIMITED INFORMATION IS AVAILABLE AT THIS TIME. THE REP WAS CALLED BY THE FACILITY CONTACT AND INFORMED THAT THE PRODUCT WAS NOT WORKING CORRECTLY. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THE PROCEDURE IS UNKNOWN. THE TISSUE THE DEVICE WAS USED ON IS UNKNOWN. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 29MAR2021 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER I. THERE WAS NO PATIENT INJURY. DURING INTRA-ABDOMINAL PROCEDURE" THE REPOSABLE GRASPER SCREW LOOSENED. AFTER REMOVAL FROM THE PORT, THE GRASPER FELL APART INTO 3 PIECES. NO PHOTOS ARE AVAILABLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 29MAR2021 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER I. THIS HAPPEN AT THE BEGINNING OF THE CASE. ENDED UP USING ANOTHER GRASPER AND IT WORKED JUST FINE. 12MM TROCAR WAS THE SIZE AND NOTHING FELL INTO THE PATIENT. INTERVENTION: USED ANOTHER PRODUCT TO COMPLETE THE CASE PATIENT STATUS: THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758236 ↗
• MalfunctionAug 31, 2020Material Separation; Material Separation

  PROCEDURE PERFORMED: UNK MATERIAL PAD INSIDE THE GRASPER STARTED TO FRAY. ANOTHER PRODUCT WAS OPENED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM CUSTOMER RELATIONS, [NAME] ON 26AUG2020: RECEIVED 3 PICTURES OF UNIT DEVICE. INTERVENTION: PRODUCT WAS REPLACED WITH ANOTHER. PATIENT INFORMATION: PATIENT IS FINE, AND COMPLETELY UNAFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10472204 ↗
• InjuryJun 18, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  NAME OF PROCEDURE BEING PERFORMED: BARIATRIC PROCEDURES. DETAILED DESCRIPTION OF EVENT: "THIS HOSPITAL IS A HIGH VOLUME ACCOUNT WITH THE C4121 AND C4120. THEY AVERAGE AROUND 30 BOXES A QUARTER FOR THESE CODES AND HAVING BEEN ORDERING THE REPOSABLE GRASPER FOR OVER 10 YEARS NOW. THIS IS A BARIATRIC HOSPITAL, SO THE ATRAUMATIC PART OF THE JAWS IS OF HIGH IMPORTANCE TO THESE SURGEONS. HERE IS A LIST OF COMPLAINTS FOR THE NEW UPGRADED GRASPERS: PADS ARE NOW SLIPPING OFF TISSUE. THE PADS ARE THINNER AND LESS QUALITY. THE JAWS ARE MORE BLUNT CAUSING MORE TRAUMA TO THE TISSUE. THE SURGEONS WHO ARE GIVING THIS FEEDBACK ARE [NAME]. THEY WANT TO DO A VALIDATIONS OF THE CHANGES WHEN THEY ARE APPLIED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15JUN2020 FROM [NAME]. THE HOSPITAL HAS NOT FILLED OUT A CER FORM. THIS HOSPITAL ONLY ORDER THE C4121. "HERE ARE THE LOT NUMBERS THEY CURRENTLY HAVE IN STOCK AND THE SURGEONS ARE STATING THE TRAUMA TO THE TISSUE IS HAPPENING ON EVERY CASE. LOT #1378864 LOT#1381850." "ON THE INJURIES THAT I'VE GOTTEN REPORTED THUS FAR IS JUST THAT THE NEW JAWS TEAR/CAUSE TRAUMA TO THE TISSUE WHEN IT'S GRASPED WHICH CAN RESULT IN BLEEDING. THERE HAS BEEN NO SIGNIFICANT B

  Patient problems: Bowel Perforation

  MAUDE report 10169378 ↗
• InjuryJun 18, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  PROCEDURE PERFORMED: BARIATRIC PROCEDURES COMPLAINT # (B)(4) (LOT 1378864, BLEEDING AND TRAUMA) COMPLAINT # (B)(4) (LOT 1381850, BLEEDING AND TRAUMA) THIS HOSPITAL IS A HIGH VOLUME ACCOUNT WITH THE C4121 AND C4120. THEY AVERAGE AROUND (B)(4) BOXES A QUARTER FOR THESE CODES AND HAVING BEEN ORDERING THE REPOSABLE GRASPER FOR OVER 10 YEARS NOW. THIS IS A BARIATRIC HOSPITAL, SO THE ATRAUMATIC PART OF THE JAWS IS OF HIGH IMPORTANCE TO THESE SURGEONS. HERE IS A LIST OF COMPLAINTS FOR THE NEW UPGRADED GRASPERS: PADS ARE NOW SLIPPING OFF TISSUE THE PADS ARE THINNER AND LESS QUALITY THE JAWS ARE MORE BLUNT CAUSING MORE TRAUMA TO THE TISSUE THE SURGEONS WHO ARE GIVING THIS FEEDBACK ARE [NAME] AND [NAME]. THEY WANT TO DO A VALIDATIONS OF THE CHANGES WHEN THEY ARE APPLIED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6)2020 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER I. THE HOSPITAL HAS NOT FILLED OUT A CER FORM. THIS HOSPITAL ONLY ORDER THE C4121. HERE ARE THE LOT NUMBERS THEY CURRENTLY HAVE IN STOCK AND THE SURGEONS ARE STATING THE TRAUMA TO THE TISSUE IS HAPPENING ON EVERY CASE. LOT 1378864 LOT 1381850 ON THE INJURIES THAT I'VE GOTTEN REPORTED THUS FAR IS JUST THAT THE NEW JAWS TEAR /

  Patient problems: Bowel Perforation

  MAUDE report 10168926 ↗
• MalfunctionApr 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LEFT ROBOTIC COLECTOMY LOWER ANTERIOR RESECTION AT THE END OF THE PROCEDURE, TWO PLASTIC PARTS CAME OFF THE END OF THE GRASPER AND WERE FOUND IN THE PATIENT. IT WAS THE RUBBER INSERTS CAME OFF. RETRIEVED FROM THE PATIENT AND THERE WAS NO HARM. ADDITIONAL INFORMATION WAS RECEIVED VIA TELEPHONE ON 08MAR2019 FROM APPLIED MEDICAL HEALTH SYSTEM SPEC: THE DEVICE WAS USED ON BOWEL USING A ROBOT AND NEEDLE DRIVER. THE PROCEDURE WAS LEFT ROBOTIC COLECTOMY LOWER ANTERIOR RESECTION. THE PATIENT IS 77 YEAR OLD 187 POUND MALE. THIS WAS THE ONLY INFORMATION AVAILABLE. PATIENT STATUS: FINE TYPE OF INTERVENTION: RETRIEVED FROM THE PATIENT AND THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8481087 ↗
• InjuryOct 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ROBOTIC LEFT SIGMOID COLECTOMY - "A ROBOTIC LEFT SIGMOID COLECTOMY WAS PERFORMED ON (B)(6). ON (B)(6) THE PATIENT WAS BROUGHT BACK TO SURGERY FOR A SMALL BOWEL LEAK REPAIR. CONCERN WAS THAT THE SMALL BOWEL WAS DAMAGED WHILE BEING RETRACTED VIA THE REPOSABLE GRASPERS DURING THE (B)(6) SURGERY THAT LED TO THE PATIENT NEEDING A SECOND SURGERY ON (B)(6)." ADDITIONAL INFORMATION RECEIVED VIA EMAIL/PHONE FROM APPLIED MEDICAL TEAM MEMBERS - CASE WAS COMPLETED AND 2-3 DAYS AFTER THE PATIENT CAME BACK TO THE HOSPITAL. FOUND THAT THERE TEARS/HOLES IN THE PATIENT'S BOWEL. OR TEAM DETERMINED THAT GRASPERS WERE USED IN THIS CASE AND CONCLUDED THAT THE TEARS / HOLES CAN BE ATTRIBUTED TO THE GRASPERS USED. IT WAS CONFIRMED THAT THE SURGEON WAS MANIPULATING THE TISSUE AND USING THE DEVICE IN BOTH CASES TYPE OF INTERVENTION- PATIENT NEEDED A SECOND SURGERY.

  Patient problems: Bowel Perforation; Injury

  MAUDE report 6031831 ↗
• InjuryOct 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ROBOTIC ASSISTED LEFT SIGMOID COLECTOMY- "DURING A (B)(6) ROBOTIC ASST. LEFT SIGMOID COLECTOMY, THE DR. NOTICED TWO HOLES IN THE SMALL BOWEL THAT NEEDED TO BE REPAIRED AND A SEW OVER ENTEROTOMY WAS PERFORMED. THE DR NOTICED THE HOLES IN THE SMALL BOWEL WAS CONSISTENT WITH THE SIZE AND SHAPE OF THE LATIS PADS ON THE DIRECT DRIVE GRASPERS." ADDITIONAL INFORMATION RECEIVED VIA EMAIL/PHONE FROM APPLIED MEDICAL TEAM MEMBERS ON SEPTEMBER 22, 2016 - WHILE DOCTOR WAS GRASPING TISSUE, FOUND TWO SMALL HOLES THAT WERE A SIMILAR SIZE TO THE LATIS MESH PADS. OR TEAM DETERMINED THAT GRASPERS CAUSED THE TEARS/HOLES. ENTEROTOMY WAS PERFORMED AS INTERVENTION. IT WAS CONFIRMED THAT THE SURGEON WAS MANIPULATING THE TISSUE AND USING THE DEVICE IN BOTH CASES. TYPE OF INTERVENTION- "ENTEROTOMY PERFORMED AND PROCEDURE CONTINUED." PATIENT STATUS: INJURY.

  Patient problems: Bowel Perforation; Injury

  MAUDE report 6031067 ↗
• MalfunctionOct 12, 2016Mechanical Problem; Mechanical Problem

  OMEGA LOOP- "SURGEON USING GRASPER TO MEASURE BOWEL, GRAPER SCISSORED - REPLACEMENT REQUESTED. CONCERN ABOUT THIS DUE TO PREVIOUS EVENT WITH ANOTHER SURGEON'S PATIENT & OUTCOME. PLEASE CONTACT DR. (B)(6) FOR MORE SPECIFIC DETAILS." PATIENT STATUS - "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6024540 ↗
• MalfunctionJun 25, 2016Mechanical Problem; Mechanical Problem

  "SURGEON USING GRASPER TO MEASURE BOWEL, GRASPER SCISSORED - REPLACEMENT REQUESTED. CONCERN ABOUT THIS DUE TO PREVIOUS EVENT WITH ANOTHER SURGEON'S PATIENT AND OUTCOME. PLEASE CONTACT DR. (B)(6) FOR MORE SPECIFIC DETAILS." PATIENT STATUS - "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5749442 ↗
• MalfunctionFeb 29, 2016Material Separation; Material Separation

  LAPAROSCOPIC COLON CASE - "DURING MD'S LAPAROSCOPIC COLON CASE A PORTION OF A LAPAROSCOPIC GRASPER TIP FELL OFF (ONE SIDE OF GRASPER TIP APPEARED FRAYED AND WORN AFTER IT WAS IN USE). GRASPING TIPS WERE BOTH INTACT UPON OPENING PACKAGE. THE PIECE WAS FOUND AND PULLED OUT. TWO GRASPERS WERE USED. UNSURE WHICH FAILED, SO BOTH ARE BEING REPORTED." PATIENT STATUS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5469416 ↗
• MalfunctionFeb 29, 2016Material Separation; Material Separation

  LAPAROSCOPIC COLON CASE - "DURING MD'S LAPAROSCOPIC COLON CASE A PORTION OF A LAPAROSCOPIC GRASPER TIP FELL OFF (ONE SIDE OF GRASPER TIP APPEARED FRAYED AND WORN AFTER IT WAS IN USE). GRASPING TIPS WERE BOTH INTACT UPON OPENING PACKAGE. THE PIECE WAS FOUND AND PULLED OUT. TWO GRASPERS WERE USED. UNSURE WHICH FAILED, SO BOTH ARE BEING REPORTED."PATIENT STATUS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5469310 ↗