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EndoWrist 48630WRecalls & reported problems

Intuitive Surgical, Inc. · STAPLER 30 RELOAD WHITE · Class 2 · Implant

All models of EndoWrist (62)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Intuitive Surgical EndoWrist white reload is a disposable stapling cartridge used in da Vinci robotic surgery to close and cut tissue and blood vessels. Most of the 31 reports describe the stapler failing to fire or misfiring mid-procedure, sometimes leaving loose staples in the surgical site, a blade stuck inside the reload, or an incomplete staple line that caused bleeding. Reports mention 1 death and 19 injuries. There are no recalls for 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
31
Deaths reported
1
Injuries reported
19
Recalls naming it
0

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00886874112861), received between Aug 13, 2020 and Aug 13, 2026 — classified as 1 death, 19 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (10 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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 3 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 2 reportsMay 2024: 1 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 3 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 2 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Firing Problem10
  • Failure to Fire8
  • Failure to Form Staple5
  • Misfire5
  • Detachment of Device or Device Component3
  • Adverse Event Without Identified Device or Use Problem2
  • Failure to Cut2
  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions13
  • Hemorrhage/Blood Loss/Bleeding11
  • Unspecified Tissue Injury8
  • Foreign Body In Patient3
  • Insufficient Information2
  • Unspecified Vascular Problem1

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 13, 2026Failure to Fire

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50241868 ↗
  • DeathAug 13, 2026Insufficient Device Problem Information

    It was reported that during a da Vinci-assisted pulmonary lobectomy, the patient experienced bleeding and despite subsequent control of the bleeding, the patient developed asystole and expired. During the procedure, a right upper lobe tumor was identified. The superior pulmonary vein was isolated while preserving the middle pulmonary vein and Boyden arterial trunk. The pulmonary vessels were dissected and divided using a Curved Tip EndoWrist 30 Stapler with a White Reload, as confirmed by system logs. Approximately one hour later, during dissection of the pulmonary ligament, a sudden massive hemorrhage occurred in the hilar region. The procedure was emergently converted to an open thoracotomy. The bleeding source was identified as the previously stapled pulmonary artery stump. Hemorrhage control measures, including hilar clamping, blood salvage, and resuscitative efforts, were performed, however, the patient expired intraoperatively.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 50235259 ↗
  • MalfunctionJul 22, 2025Firing Problem; Firing Problem

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22572463 ↗
  • MalfunctionJul 21, 2025Firing Problem; Firing Problem

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, A STAPLER 30 WHITE RELOAD WAS INSTALLED ON A CURVED-TIP STAPLER 30 INSTRUMENT AND THE STAPLER FIRE COULD NOT BE COMPLETED. THE USER WAS ATTEMPTING TO STAPLE THE PULMONARY VESSELS AND NO CLAMPING OTHER THAN THE PULMONARY VESSELS WAS ALLOWED. ON THE FIRST STAPLER FIRE, THE BLADE STOPPED IN THE MIDDLE OF THE RELOAD. ON THE SECOND STAPLER FIRE, THE BLADE DID NOT RUN AND THE STAPLER FIRE FAILED. ON THE THIRD STAPLER FIRE, IT WAS PERFORMED USING A CURVED-TIP STAPLER 30 INSTRUMENT PREPARED SEPARATELY FROM THE FIRST AND SECOND STAPLER FIRES, BUT THE BLADE STOPPED IN THE MIDDLE OF THE RELOAD; THE SAME AS THE FIRST OCCURRENCE. THE SURGEON INFORMED THAT THE SOUND OF OPERATION DURING THE STAPLE FIRE WAS DIFFERENT FROM USUAL AND SOUNDED LIKE A CREAKING SOUND. 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: THE FIRST TO THIRD STAPLER FIRE WAS INVOLVED WITH THE REPORTED EVENT. THE STAPLER INSTRUMENT DID NOT WORK AT ALL. STAPLING FIRE WAS BEING PERFORM

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22560968 ↗
  • MalfunctionJul 21, 2025Firing Problem; Firing Problem

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, A STAPLER 30 WHITE RELOAD WAS INSTALLED ON A CURVED-TIP STAPLER 30 INSTRUMENT AND THE STAPLER FIRE COULD NOT BE COMPLETED. THE USER WAS ATTEMPTING TO STAPLE THE PULMONARY VESSELS AND NO CLAMPING OTHER THAN THE PULMONARY VESSELS WAS ALLOWED. ON THE FIRST STAPLER FIRE, THE BLADE STOPPED IN THE MIDDLE OF THE RELOAD. ON THE SECOND STAPLER FIRE, THE BLADE DID NOT RUN AND THE STAPLER FIRE FAILED. ON THE THIRD STAPLER FIRE, IT WAS PERFORMED USING A CURVED-TIP STAPLER 30 INSTRUMENT PREPARED SEPARATELY FROM THE FIRST AND SECOND STAPLER FIRES, BUT THE BLADE STOPPED IN THE MIDDLE OF THE RELOAD: THE SAME AS THE FIRST OCCURRENCE. THE SURGEON INFORMED THAT THE SOUND OF OPERATION DURING THE STAPLE FIRE WAS DIFFERENT FROM USUAL AND SOUNDED LIKE A CREAKING SOUND. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE STAPLER INSTRUMENT DID NOT WORK AT ALL. STAPLING FIRE WAS BEING PERFORMED AT THE TIME OF THE EVENT. THE TARGET TISSUE WAS THE VESSEL. THE TISSUE WAS NOT CALCIFIED. THERE WAS NO TISSUE TENSION

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22558964 ↗
  • InjuryApr 28, 2025Detachment of Device or Device Component; Firing Problem; Detachment of Device or Device Component; Firing Problem

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, LOOSE STAPLES FELL INTO THE PATIENT¿S SURGICAL SITE AFTER A FIRING FAILURE OCCURRED WITH THE ENDOWRIST 30 STAPLER INSTRUMENT, EQUIPPED WITH A WHITE RELOAD ACCESSORY. THE FIRING FAILURE OCCURRED WHILE STAPLING THE PULMONARY ARTERY, THE SURGEON FIRED OVER AN EXISTING STAPLE LINE, AND A MESSAGE STATING "UNABLE TO COMPLETE FIRE, BLADE MAY BE EXPOSED" WAS NOTED. IT IS UNKNOWN IF THE LOOSE STAPLES WERE RETRIEVED; HOWEVER, THERE WAS NO UNPLANNED TISSUE REMOVAL OR BLEEDING AS A RESULT OF THE EVENT AND THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Patient problems: Foreign Body In Patient

    MAUDE report 21921519 ↗
  • MalfunctionMar 13, 2025Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE USING A STAPLER 30 CURVED-TIP INSTRUMENT, THE RELOAD AND STAPLER DID NOT RELEASE ONCE DEPLOYED. THE TARGET TISSUE INVOLVED WAS THE LUNG. THE STAPLER WAS CLAMPED AND WOULD NOT DISENGAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21599977 ↗
  • InjuryOct 22, 2024Misfire; Misfire

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT PULMONARY LOBECTOMY PROCEDURE, THERE WAS BLEEDING DUE TO AN INCOMPLETE STAPLE LINE WHERE THE SURGEON HAD FIRED 2 WHITE STAPLER 30 RELOADS WITH AN ENDOWRIST 30 CURVED-TIP STAPLER INSTRUMENT. THE STAPLER INSTRUMENT WAS INSPECTED PRIOR TO USE, AND THERE WERE NO ISSUES NOTED. DURING THE FIRING PROCESS, THE STAPLER RELOAD DEPLOYED STAPLES UNEXPECTEDLY, CAUSING HOLES AND GAPS WITHIN THE STAPLE LINE; AND TISSUE WAS CUT. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS OR MATERIAL BETWEEN THE INSTRUMENT JAWS, AND NO ERROR MESSAGES WERE DISPLAYED. THE AMOUNT OF BLEEDING IS UNKNOWN; HOWEVER, THE PATIENT DID NOT REQUIRE A TRANSFUSION OF ANY BLOOD PRODUCTS. THE BLEEDING OCCURRED FROM A VEIN IN THE LEFT UPPER LOBE AND THE S1+S2 ARTERY; AND WAS RESOLVED WITH COMPRESSION OF THE VEIN, USE OF HEMOSTATIC AGENT(S), AND USING A THIRD-PARTY STAPLER INSTRUMENT. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE STAPLING ISSUE, AND WAS COMPLETED. THE PATIENT TOLERATED THE CONVERSION AND THERE WERE NO POST-OPERATIVE COMPLICATIONS.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

    MAUDE report 20511201 ↗
  • InjuryOct 22, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT PULMONARY LOBECTOMY PROCEDURE, THERE WAS BLEEDING DUE TO AN INCOMPLETE STAPLE LINE, AFTER THE SURGEON TRIED STAPLING USING 2 WHITE ENDOWRIST 30 CURVED-TIP RELOAD ACCESSORIES. THE STAPLER WAS INSPECTED PRIOR TO USE, AND THERE WERE NO ISSUES NOTED. DURING THE FIRING PROCESS, THE RELOAD DEPLOYED STAPLES UNEXPECTEDLY, CAUSING HOLES AND GAPS WITHIN THE STAPLE LINE; AND THE STAPLER CUT THE TISSUE. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS OR MATERIAL BETWEEN THE INSTRUMENT JAWS, AND NO ERROR MESSAGES WERE DISPLAYED. THE AMOUNT OF BLEEDING IS UNKNOWN; HOWEVER, THE PATIENT DID NOT REQUIRE A TRANSFUSION OF ANY BLOOD PRODUCTS. THE BLEEDING OCCURRED FROM A VEIN IN THE LEFT UPPER LOBE AND THE S1+S2 ARTERY, AND WAS RESOLVED WITH COMPRESSION OF THE VEIN, USE OF A HEMOSTATIC, AND USING A THIRD-PARTY STAPLER INSTRUMENT. THE PROCEDURE WAS CONVERTED TO OPEN DUE TO THE STAPLING ISSUE AND WAS COMPLETED. THE PATIENT TOLERATED THE CONVERSION AND THERE WERE NO POST-OPERATIVE COMPLICATIONS.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

    MAUDE report 20509858 ↗
  • InjuryJun 4, 2024Failure to Form Staple; Failure to Form Staple

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 19461716 ↗
  • MalfunctionMay 9, 2024No Device Output; No Device Output

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE LONG BIPOLAR GRASPER INSTRUMENT HAD A WIRE BROKEN. FAILURE ANALYSIS INVESTIGATION OBSERVED A STAPLE INTERTWINED IN THE GRIP CABLE OF THE LONG BIPOLAR GRASPER INSTRUMENT RETURNED ON RMA 301858310010 LINKED TO (B)(4). THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19275168 ↗
  • MalfunctionApr 11, 2024Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CURVED-TIP 30 STAPLER 30 INSTRUMENT HAD REMNANTS OF THE STAPLES THAT WERE GETTING STUCK IN THE JAWS OF THE INSTRUMENT EACH TIME IT WAS FIRED. THE CUSTOMER HAD TO DOUBLE CHECK THE STAPLER TO MAKE SURE NO STAPLES WERE STUCK BEFORE THEY WERE RELOADED; OTHERWISE, IT WOULD NOT LET THEM RELOAD IT PROPERLY. THE STAPLES WERE STILL STUCK AFTER USE OF THE INSTRUMENT WAS COMPLETED. THIS WAS AN ISSUE WHEN SENDING THE INSTRUMENT FOR REPROCESSING. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19093394 ↗
  • InjuryApr 4, 2024Firing Problem; Firing Problem

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 19043662 ↗
  • MalfunctionJan 30, 2024Firing Problem; Firing Problem

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18610978 ↗
  • InjuryJan 5, 2024Failure to Fire; Failure to Fire

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 18450804 ↗
  • MalfunctionJan 4, 2024Detachment of Device or Device Component; Firing Problem; Detachment of Device or Device Component; Firing Problem

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CURVED-TIP STAPLER 30 INSTRUMENT STOPPED WHILE FIRING ACROSS A VESSEL. USE OF THE INSTRUMENT WAS DISCONTINUED, AND IT WAS REPLACED TO THE BACKUP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18441726 ↗
  • MalfunctionNov 14, 2023Firing Problem; Firing Problem

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CURVED TIP 30 STAPLER INSTRUMENT WAS MAKING A GRINDING NOISE AND DID NOT FIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18135449 ↗
  • InjuryJun 16, 2023Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, A WHITE STAPLER 30 RELOAD DID NOT STAPLE. THE ¿BODY¿ WAS REUSED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Patient problems: Insufficient Information

    MAUDE report 17142519 ↗
  • InjuryMay 3, 2023Failure to Form Staple; Failure to Form Staple

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 16865299 ↗
  • InjuryApr 27, 2023Firing Problem; Firing Problem

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 16826985 ↗
  • InjuryApr 24, 2023Misfire; Misfire

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOBECTOMY SURGICAL PROCEDURE, THE ENDOWRIST 30 CURVED-TIP STAPLER INSTRUMENT MADE A GRINDING NOISE; HOWEVER, THE SURGEON CONTINUED TO FIRE ON THE PULMONARY ARTERY WITH A WHITE STAPLER 30 RELOAD. THE STAPLER FAILED MIDWAY THROUGH THE STAPLE LINE. THERE WAS A SYSTEM-GENERATED MESSAGE INDICATING A BLADE WAS EXPOSED. THE SURGEON HESITATED TO UNCLAMP THE STAPLER AS IT WAS CLAMPED DOWN ON THE PULMONARY ARTERY. HENCE HE USED A HAND-HELD LAPAROSCOPIC STAPLER INSTRUMENT INSTALLED THROUGH A DA VINCI 12MM PORT, STAPLED MEDIALLY TO THE MISFIRED STAPLE LINE, AND COMPLETED THE STAPLE LINE. IT WAS CONFIRMED THAT THERE WAS NO BLEEDING, AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT WAS REPORTED TO BE RECOVERING WELL.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 16799291 ↗
  • InjuryFeb 7, 2023Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE CURVED-TIP STAPLER 30 INSTRUMENT FIRED A WHITE RELOAD ACROSS AN ARTERY THAT FORMED AN INCOMPLETE STAPLE LINE AND CAUSED BLEEDING. THE SURGEON USED A LAPAROSCOPIC STAPLER TO RESOLVE THIS EVENT BY CREATING ANOTHER STAPLE LINE NEAR THE WHITE RELOAD LINE THAT BLED. THE CUSTOMER THEN REMOVED THIS CURVED-TIP STAPLER 30 INSTRUMENT AND REPLACED IT WITH ANOTHER TO CONTINUE THE PROCEDURE. THE CUSTOMER REPORTED THAT THIS 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: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

    MAUDE report 16315710 ↗
  • InjuryDec 10, 2022Firing Problem; Firing Problem

    AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED AFTER THE PROCEDURE TO REPORT THAT DURING A DA VINCI-ASSISTED THORACIC PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE STAPLER 30 INSTRUMENT HAD FAILED DURING FIRING. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED FIRING FAILURE FROM STAPLER 30. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI PERFORMED FOLLOW-UPS AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO SURGICAL DELAY REPORTED. THE INSTRUMENT CAME FROM THE STERILE PROCESSING DEPARTMENT (SPD) AND NOTHING WAS OUT OF THE ORDINARY. THERE WERE STAPLING ACROSS FISSURE AND THE STAPLER MISFIRED ON THE FIRST USE. THE ERROR MESSAGE WAS THAT THE INSTRUMENT WAS UNABLE TO COMPLETE THE FIRE AND THE BLADE MAY BE EXPOSED. THE INSTRUMENT BLADE WAS FOUND TO BE EXPOSED, AND THE STAPLES WERE NOT CLOSED. NO BUTTRESS MATERIAL WAS USED. THERE WERE NO CLAMPING ISSUES. THE TARGET TISSUE WAS THE LUNG. THE SURGEON WAS ABLE TO RESOLVE THE ISSUE. NO IMAGES OR VIDEO RECORDINGS AVAILABLE FOR REVIEW. ADDITIONAL FOLLOW UP CONFIRMED THAT THERE WERE LOOSE STAPLES THAT REMAINED IN THE PATIENT¿S BODY. NO STAPLES WERE MISSING FRO

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15956036 ↗
  • InjuryAug 26, 2022Failure to Fire; Failure to Fire

    INTUITIVE SURGICAL INC. (ISI) RECEIVED FDA VOLUNTARY REPORT WITH MDR REPORT #MW5110971 STATING: ¿PT SCHEDULED FOR ROBOTIC-ASSISTED LEFT UPPER LOBECTOMY. EMERGENTLY CONVERTED TO OPEN PROCEDURE DUE TO BLEEDING. IT APPEARED THAT ALL OF THE STAPLES DIDN¿T DEPLOY AND THE BLADE WAS STILL EXPOSED, CAUSING VASCULAR INJURY AND EXSANGUINATION OF 4200ML OF BLOOD 30MM STAPLER USED REF#(B)(4), LOT # T102101040042 WITH LOAD MODEL #48630W, LOT M90210503. FDA SAFETY REPORT ID# (B)(4).¿ 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: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 15307278 ↗
  • InjuryAug 12, 2022Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SURGEON USED AN ENDOWRIST CURVED-TIP STAPLER 30 INSTRUMENT, CLAMPED ON THE PULMONARY ARTERY (PA), FIRED, AND THEN RECEIVED AN ERROR MESSAGE THAT THE BLADE WAS EXPOSED. THE STAPLER INSTRUMENT WOULD NOT UNCLAMP. AN EMERGENT RELEASE KEY HAD TO BE USED TO REMOVE THE STAPLER INSTRUMENT. THERE WAS SOME MINOR BLEEDING. ALL THE STAPLES WERE RELEASED ON THE FIRST FIRE BUT DID NOT TRANSCEND THROUGH TISSUE. THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY BECAUSE THE SURGICAL STAFF DID NOT TRUST THE INTEGRITY OF THE STAPLER. AN INTUITIVE SURGICAL, INC. (ISI) SENIOR CLINICAL SALES REPRESENTATIVE (CSR) WAS CONTACTED BY THE SURGEON WHEN THE INCIDENT OCCURRED. THE SURGICAL STAFF WAS ABLE TO USE THE STAPLER RELEASE KEY (SRK) TO RELEASE THE STAPLER INSTRUMENT THAT HAD A FIRING FAILURE ON THE PA. THE SURGICAL STAFF WAS ABLE TO REMOVE THE STAPLER INSTRUMENT, AND IT WAS REPORTED THERE WAS SOME MINOR BLEEDING FROM THE PA. THE SURGEON ESTIMATED THE BLOOD LOSS TO BE ABOUT 25-50ML FOR THE CASE. THERE WERE SOME FORMED STAPLES; HOWEVER, THE TISSUE WAS NOT TRANSECTED. THERE WERE SOME MALFORMED STAPLES AND

    Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

    MAUDE report 15219238 ↗

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