SureForm 48345WRecalls & reported problems
Intuitive Surgical, Inc. · SUREFORM 45 RELOAD WHITE · Class 2 · Implant
All models of SureForm (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This SureForm stapler reload is a single-use staple cartridge used with da Vinci surgical systems. Reports mostly describe firing problems during lung surgery—misfires, incomplete staple lines, tissue jams, and bleeding that sometimes required converting to open surgery. There are 40 reports mentioning it: no deaths, 27 injuries, and 13 malfunctions. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00886874117125), received between May 22, 2021 and Sep 23, 2026 — classified as 25 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Firing Problem” (15 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.
Reports received per month
Most reported problems
Device problems
- Firing Problem15
- Failure to Form Staple9
- Failure to Fire8
- Break5
- Detachment of Device or Device Component4
- Material Fragmentation4
- Appropriate Device Problem Term/Code Not Available1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Hemorrhage/Blood Loss/Bleeding11
- Unspecified Tissue Injury7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Foreign Body In Patient2
- Insufficient Information1
- Perforation of Vessels1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Break; Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875357 ↗MalfunctionSep 23, 2026Material Fragmentation
It was reported that during a da Vinci-assisted surgical procedure, the Sureform 45 Stapler was unable to open. The customer was unsure if firing had occurred. The surgeon engaged the enhanced force and the tissue was stapled and cut completely. The user completed the procedure using a backup stapler with no further issue reported. No fragment fell inside the patient. No known impact or patient consequence was reported.ISI followed up with the initial reporter and obtained the following additional information: The instrument was able to staple and cut normally. There was no stapling issue. This occurred while using a white reload. The customer was able to open the jaws successfully. There was no bleeding observed and no unplanned tissue removal. The customer used a new stapler to continue the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864019 ↗MalfunctionSep 1, 2026Firing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50536892 ↗InjuryAug 31, 2026Firing Problem
It was reported that during a da Vinci-assisted pulmonary lobectomy surgical procedure, the White SureForm 45 Reload staple line bled after a misfire; the staple line was incomplete. The site reported being required to manually select the Reload color from the Surgeon Side Console before the fire. The SureForm 45 Curved-Tip Stapler was replaced with a backup stapler. After a successful firing sequence, no error messages were observed; the White staple line bled and required intervention. The surgeon reports the level of bleeding produced from the staple line was unexpected; the estimated blood loss was not provided. The bleeding was controlled intraoperatively; the procedure was completed robotically with a backup reload.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 50524123 ↗InjuryJun 12, 2026Firing Problem
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, HALFWAY THROUGH THE STAPLING PROCESS WITH A SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT AND A SUREFORM 45 WHITE RELOAD, AN ERROR MESSAGE APPEARED TO PAUSE FOR COMPRESSION. THE STAPLING CONTINUED, AND BEFORE COMPLETION, THE DEVICE JAMMED AND A SECOND MESSAGE INDICATING TISSUE WAS TOO THICK, STAPLING IMPOSSIBLE APPEARED. THIS RESULTED IN A PARTIALLY SEVERED STUMP OF THE PULMONARY ARTERY BRANCH. APPROXIMATELY 120 ML OF BLOOD LOSS OCCURRED. COMPRESSION HEMOSTASIS, FOLLOWED BY ELECTRICAL HEMOSTASIS AND THE APPLICATION OF HEMOSTATIC AGENT (I.E. TACHOSIL) WAS PERFORMED TO CONTROL THE BLEEDING. THIS ISSUE CAUSED A DELAY BETWEEN 15 AND 30 MINUTES: TIME REQUIRED TO SAFELY REMOVE THE STAPLER, RE-CUT THE PARTIALLY SEVERED STUMP, PERFORM PRIMARY HEMOSTASIS, AND THEN RECHECK THE STAPLE LINE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25492037 ↗InjuryApr 11, 2026Firing Problem
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE SUREFORM 45 WHITE RELOAD STAPLE LINE WAS INCOMPLETE, CAUSING A LEAK. IT IS UNKNOWN WHAT INTERVENTION WAS REQUIRED TO ADDRESS THE LEAK. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 24847766 ↗InjuryFeb 12, 2026Firing Problem
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, A PARTIAL FIRE OCCURRED WHEN A SUREFORM 45 WHITE RELOAD WAS FIRED WITH A SUREFORM CURVED-TIP 45 STAPLER INSTRUMENT. DURING LUNG RESECTION, THE CUSTOMER WAS STAPLING ACROSS THE PULMONARY ARTERY WHEN IN THE MIDDLE OF THE FIRING, THE STAPLER STOPPED WORKING. THE STAPLES ENGAGED UP TO THE POINT OF THE KNIFE BLADE. THERE WERE NO MALFORMED OR UNFORMED STAPES, NO VISUAL EXPOSURE OF THE BLADE, AND NO TISSUE WAS STUCK TO THE RELOAD. THE CUSTOMER REPORTED STAPLES MISSING FROM THE STAPLE LINE THERE WERE NO HOLES OR GAPS WITHIN THE STAPLE LINE. THERE WERE NO ERROR MESSAGES. THE CUSTOMER REPORTED THAT MINIMAL BLEEDING WAS OBSERVED BUT UNEXPECTED. NO BLOOD TRANSFUSION WAS REQUIRED. HOWEVER, THE FOLLOWING INFORMATION IS UNKNOWN: THE SOURCE AND CAUSE OF THE BLEEDING, THE ESTIMATED BLOOD LOSS ASSOCIATED WITH THE BLEEDING, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. A NEW STAPLER WAS INSTALLED AND THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24329476 ↗MalfunctionFeb 2, 2026Break; Material Fragmentation
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, WHILE STAPLING (CUTTING) A BLOOD VESSEL, THE MESSAGE ¿TISSUE TOO THICK TO CONTINUE¿ APPEARED. THE INSTRUMENT WAS REMOVED FROM THE PATIENT BODY, AND WHEN THE RELOAD WAS DETACHED, THE RELOAD¿S KNIFE TRACK WAS FOUND TO BE SHAVED/ABRADED. NO FRAGMENT FELL INTO THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: NO FRAGMENT FELL INTO THE PATIENT¿S BODY, AND THE ABSENCE OF FRAGMENTS WAS CONFIRMED DURING THE PROCEDURE. THERE IS NO INSTRUMENT RETURN. NO IMAGES ARE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24230899 ↗InjuryAug 26, 2025Firing Problem; Firing Problem
IT REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT UPPER LOBECTOMY PROCEDURE, THE FIRING SEQUENCE OF A SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT WITH A WHITE SUREFORM 45 RELOAD, STOPPED MIDWAY ACROSS THE SUPERIOR PULMONARY VEIN. AN ERROR MESSAGE WAS OBSERVED STATING, "TISSUE TOO THICK TO CONTINUE". DUE TO THE HIGH RISK OF HEMORRHAGE, THE PROCEDURE WAS CONVERTED TO AN OPEN THORACOTOMY TO SAFELY REMOVE THE STAPLER INSTRUMENT. THE ATRIAL ORIFICE WAS SECURED, AND UPON REMOVAL OF THE STAPLER INSTRUMENT, THE VEIN WAS FOUND TO BE PARTIALLY TRANSECTED AND SEALED. DETAILS REGARDING THE RESOLUTION OF THE ISSUE OR THE PATIENT'S CURRENT CONDITION REMAIN UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 22895198 ↗InjuryAug 21, 2025Material Fragmentation; Material Fragmentation
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22860071 ↗InjuryAug 8, 2025Firing Problem; Firing Problem
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Unspecified Tissue Injury
MAUDE report 22759269 ↗MalfunctionJul 21, 2025Break; Break
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, WHEN USING THE SUREFORM 45 STAPLER, THE PROCEDURE WAS SUSPENDED DURING COMPRESSION. COMPRESSION, STAPLING, AND THEN CUTTING WERE PERFORMED. UPON REMOVAL OF THE SUREFORM 45 WHITE RELOAD, A HARD MATERIAL (RESEMBLING PLASTIC) WAS FOUND IN THE CUTTING RAIL. USE OF THE INSTRUMENT WAS DISCONTINUED, AND IT WAS REPLACED TO THE BACKUP. NO FRAGMENT FELL INTO THE PATIENT. THE USER COMPLETED THE PROCEDURE, AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: WHEN USING THE STAPLER, THE PROCEDURE WAS PAUSED DURING COMPRESSION. COMPRESSION THEN CONTINUES, FOLLOWED BY STAPLING AND CUTTING. WHEN THE STAPLER RELOAD WAS REMOVED, HARD MATERIAL WAS FOUND IN THE CUTTING RAIL. THE IDENTIFIED HARD MATERIAL WAS NOT DETACHED/FALL OF THE RELOAD. NO FRAGMENT FELL INTO THE PATIENT¿S ANATOMY. THE REPORTED EVENT CAUSED A DELAY OF LESS THAN 15 MINUTES. THERE WAS A PRESENCE OF A HARD MATERIAL RESEMBLING PLASTIC IN THE CUTTING RAIL/AT THE CUTTING RAIL WHEN REMOVING THE RELOAD FROM THE STAPLER. THERE ARE NO PHOTOS OF THE INSTR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561119 ↗InjuryJun 24, 2025Firing Problem; Firing Problem
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22323347 ↗InjuryMay 22, 2025Firing Problem; Firing Problem
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, A PARTIAL FIRE OCCURRED USING A SUREFORM 45 STAPLER INSTRUMENT WITH A WHITE SUREFORM 45 RELOAD, RESULTING IN MINOR BLEEDING. THE STAPLER INSTRUMENT HAD SUCCESSFULLY COMPLETED THE FIRING OF THE FIRST STAPLER RELOAD, PRIOR TO THE INCIDENT. THE PARTIAL FIRE HAPPENED DURING THE SECOND ATTEMPT TO STAPLE A VESSEL, WHILE PERFORMING VASCULAR DISSECTION. THE TISSUE WAS NOT UNDER ANY TENSION AND THERE ALSO WAS NO TISSUE BUNCHING. HOWEVER, THE TISSUE HAD PREVIOUSLY BEEN SUBJECTED TO RADIATION OR CHEMOTHERAPY. THE SURGEON DID NOT FIRE OVER AN EXISTING LINE. THE FOLLOWING ERROR MESSAGES APPEARED DURING THE EVENT, "BLADE MAY BE EXPOSED" AND "TISSUE TOO THICK TO CONTINUE." THE BLADE WAS INDEED EXPOSED. ALTHOUGH THE STAPLE LINE SHOWED NO HOLES OR GAPS, SOME STAPLES WERE MISSING FROM THE LINE. A MINOR AMOUNT OF BLEEDING, DESCRIBED AS "OOZING," WAS OBSERVED ALONG THE STAPLE LINE. THE BLEEDING WAS MANAGED WITH THE APPLICATION OF PRESSURE USING COTTON PADS, AND THE PATIENT DID NOT REQUIRE A TRANSFUSION. UPON INSPECTION, THE WHITE SUREFORM 45 RELOAD WAS FOUND TO HAVE STAPLES REMAINING IN THE TRACK. THE ANVIL WAS THEN REMOVED
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22070738 ↗InjuryMay 13, 2025Material Fragmentation; Firing Problem; Material Fragmentation; Firing Problem
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT MIDDLE PULMONARY LOBECTOMY PROCEDURE, A PARTIAL FIRE OCCURRED ON THE PULMONARY ARTERY WHEN THE SURGEON FIRED A WHITE SUREFORM 45 RELOAD WITH A SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT. WHEN THE EVENT OCCURRED, AN ERROR MESSAGE WAS OBSERVED STATING ¿TISSUE TOO THICK TO CONTINUE.¿ THE EVENT RESULTED WITH THE DEPLOYMENT OF UNFORMED STAPLES THAT WERE PARTIALLY STUCK IN TISSUE. THE SURGICAL TEAM THEN PREPARED TO SWITCH TO AN OPEN APPROACH, BUT THEY MANAGED TO SUCCESSFULLY UNCLAMP AND REMOVE THE STAPLER INSTRUMENT FROM THE PATIENT. UPON INSPECTION, THE WHITE SUREFORM 45 RELOAD REVEALED THAT THE STAPLES IN THE INITIAL THIRD OF THE CARTRIDGE WERE CORRECTLY FORMED IN A B-SHAPE, WHEREAS THE REMAINING STAPLES WERE U-SHAPED. THE TIPS OF THE UNFORMED STAPLES, WHICH HAD FALLEN OUT OF THE CARTRIDGE, WERE PARTIALLY STUCK IN THE PULMONARY ARTERY TISSUE AND WERE RETRIEVED UTILIZING A LONG BIPOLAR FORCEPS INSTRUMENT DURING THE PROCEDURE. THIS EVENT DID NOT RESULT IN ANY BLEEDING, AS THE STAPLER DEPLOYED THE STAPLES WITHOUT CUTTING THE TISSUE. A THIRD-PARTY STAPLER INSTRUMENT WAS THEN USED TO COMPLETE THE STAPLE LINE, AND THE PROCEDURE WAS COMPLET
Patient problems: Unspecified Tissue Injury
MAUDE report 22011302 ↗MalfunctionFeb 13, 2025Failure to Fire; Failure to Fire
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21379704 ↗InjuryNov 22, 2024Firing Problem; Firing Problem
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20765098 ↗InjuryNov 12, 2024Firing Problem; Firing Problem
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN INCOMPLETE STAPLE FIRE OCCURRED WHILE FIRING A WHITE SUREFORM 45 RELOAD WITH A SUREFORM 45 STAPLER INSTRUMENT. THE EVENT OCCURRED ON VASCULARIZED COLON TISSUE AND DURING THE FIRST STAPLER FIRE. THE AFFECTED COLON TISSUE STARTED BLEEDING AFTER THE INITIAL FIRING. APPROXIMATELY 20ML OF UNEXPECTED BLOOD LOSS OCCURRED AND IT WAS TAKEN CARE OF IMMEDIATELY. THE SURGEON PLACED SUTURES TO CONTROL THE BLEED. IT WAS REPORTED THAT THERE WAS UNPLANNED TISSUE REMOVAL DUE TO THE FIRING ISSUE. NO TISSUE IRREGULARITIES WERE NOTED. NO ERRORS WERE DISPLAYED BY THE SYSTEM. A NEW STAPLER INSTRUMENT AND RELOAD OF THE SAME TYPE WERE OPENED TO CONTINUE THE CASE WHICH WAS COMPLETED ROBOTICALLY.
Patient problems: Unspecified Tissue Injury
MAUDE report 20670074 ↗MalfunctionOct 16, 2024Positioning Problem; Positioning Problem
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20458598 ↗InjurySep 24, 2024Firing Problem; Firing Problem
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY, A PARTIAL FIRE OCCURRED, AND THE TISSUE DID NOT DETACH. THE ISSUE OCCURRED WHILE FIRING A SUREFORM 45 STAPLER INSTRUMENT WITH A WHITE SUREFORM 45 RELOAD ACCESSORY, AND AN ERROR MESSAGE OF ¿TISSUE TOO THICK¿ WAS OBSERVED. WHILE UNCLAMPING THE STAPLER FROM THE PULMONARY ARTERY (PA), STAPLES WERE SCATTERED IN THE BODY AND THE PA WAS NOT DISSECTED. WHEN THE EVENT OCCURRED, THE SHAPE OF THE STAPLES WERE NOT B-SHAPED AND WERE UNFORMED IN A U-SHAPE. IT IS UNKNOWN IF THE LOOSE STAPLES WERE RETRIEVED. IT WAS NOTED THAT A POST-OPERATIVE X-RAY WAS PERFORMED. THE WHITE RELOAD ACCESSORY WAS VISUALLY INSPECTED AND IT WAS NOTICED THAT INSIDE OF THE CARTRIDGE, WHERE THE KNIFE RUNS; A SCRAPE MARK WAS OBSERVED, AND THE BLADE WAS EXPOSED. THE ISSUE WAS RESOLVED BY DISSECTING THE PA USING A THIRD-PARTY STAPLER INSTRUMENT. THE PROCEDURE PROCEEDED AND WAS COMPLETED ROBOTICALLY.
Patient problems: Foreign Body In Patient
MAUDE report 20292829 ↗MalfunctionSep 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20288595 ↗MalfunctionSep 17, 2024No Device Output; Failure to Fire; No Device Output; Failure to Fire
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20243214 ↗InjurySep 4, 2024Break; Break
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, A BLUE OBJECT APPROXIMATELY 2 MM IN DIAMETER WAS DISCOVERED INSIDE THE CHEST CAVITY. IT WAS IMMEDIATELY AFTER THE SUREFORM45 WHITE FIRE. IT WAS THOUGHT THAT PART OF THE PUSHER USED TO PUSH OUT THE RELOAD STAPLE MAY HAVE FALLEN OFF. THE PIECE WAS RETRIEVED SAME PROCEDURE, AND THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS REMOVED THROUGH THE ASSIST PORT. THEY VISUALLY CONFIRMED ALL FRAGMENTS WERE RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 20139292 ↗MalfunctionAug 22, 2024Dull, Blunt; Failure to Form Staple; Dull, Blunt; Failure to Form Staple
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE WHITE SUREFORM RELOADS FROM LOT # K10240208 WERE VISUALLY GIVING A DIFFERENT TISSUE RESPONSE THAN NORMAL WITH JAGGED EDGES. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON INFORMED THAT THERE WAS NO BLEEDING OR GAPS ALONG THE STAPLE LINE. WHEN FIRING THE RELOAD, IT SEEMED TO PUSH THE TISSUE AND THERE WAS NOT A CLEAN CUT. THE SURGEON FURTHER EXPLAINED THAT THE CUT WAS JAGGED. THE CUSTOMER CONTINUED ALONG THE STAPLE LINE AFTER THE JAGGED CUT LINE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT. THE ISSUE HAD OCCURRED IN PAST PROCEDURES, BUT WAS UNABLE TO REMEMBER ANY DATES FOR WHEN THE ISSUE OCCURRED. THE CUSTOMER SALES REPRESENTATIVE (CSR) WAS NOT PRESENT FOR THE PROCEDURE. THE SURGEON WAS CONCERNED BECAUSE THE ISSUE TOOK PLACE ON A BRANCH OF THE PULMONARY ARTERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20044043 ↗InjuryAug 22, 2024Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DONOR NEPHRECTOMY PROCEDURE, AN INCOMPLETE STAPLE LINE OCCURRED WHILE STAPLING ACROSS THE RENAL ARTERY OF THE LEFT KIDNEY WITH A WHITE SUREFORM 45 RELOAD INSTALLED ON A SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT. PRIOR TO APPLYING THE STAPLER, THE SURGEON FULLY SKELETONIZED THE RENAL ARTERY. THERE WAS NO CALCIFICATION WITHIN THE ARTERY. THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT CLAMPED ON THE RENAL ARTERY WITH NO ERRORS OR ISSUES. THE FIRING PROCESS STARTED AND WHILE HALFWAY COMPLETE, THE FIRING PAUSED FOR COMPRESSION AND AN UNSPECIFIED MESSAGE WAS PRODUCED. THE FIRING STOPPED FOR APPROXIMATELY 5 SECONDS, THEN CONTINUED TO COMPLETION. WHEN THE STAPLER INSTRUMENT WAS UNCLAMPED, BLEEDING WAS IMMEDIATELY IDENTIFIED FROM THE MIDLINE OF THE STAPLE LINE. THE STAPLER INSTRUMENT WAS REMOVED AND IT WAS IDENTIFIED THAT THE MIDLINE OF THE STAPLE LINE WAS ONLY PARTIALLY SEALED. A HEM-O-LOK CLIP APPLIER WAS USED TO APPLY A CLIP IN ORDER TO SUCCESSFULLY CONTROL THE BLEEDING ON THE STAPLE LINE. NO FURTHER INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT IS RECOVERING WELL WITH NO POSTOPERATIVE COMPLICATIONS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20036217 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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