EndoWrist 48645WRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886874112885), received between Jan 20, 2021 and Mar 30, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Misfire” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE THAT THE PATIENT'S HEMOGLOBIN LEVELS AND BLOOD PRESSURE WERE LOW. THE SURGEON TOOK THE PATIENT BACK TO EXPLORE THE PATIENT TO IDENTIFY THE BLEEDING SOURCE. BLEEDING WAS NOTED TO BE COMING FROM THE MIDDLE OF A STAPLE LINE ON THE INFERIOR MESENTERIC ARTERY (IMA). THE SURGEON USED A THIRD PARTY CLIP APPLIER TO STOP THE BLEED AND THE PATIENT WAS HOSPITALIZED OVER NIGHT. THE PATIENT'S LAB RESULTS CAME BACK AND THE SURGEON DETERMINED THE PATIENT WAS STILL BLEEDING AND RE-OPERATED TO PLACE ANOTHER CLIP. ON 23-MAR-2022, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE SURGEON REPORTED THAT THIS WAS AN INTRABDOMINAL BLEED FROM THE IMA. THE SURGEON SKELETONIZED THIS VESSEL PRIOR TO THE STAPLER FIRE AND THE SUPERIOR RECTAL VESSEL WAS PRESERVED. THE SURGEON REPORTED THIS PATIENT WAS ¿THIN¿ WITH ¿MINIMAL ADIPOSE TISSUE.¿ THERE WERE NO ERRORS DURING THIS STAPLER FIRE. THE SURGEON OBSERVED NO ISSUES WITH THIS STAPLE LINE AFTER IT WAS FIRED. THE SURGEON REPORTED THE PATIENT LOST BETWEEN 500-750ML OF BLOOD DUE TO THIS EVENT; THE PATIENT DID

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13952119 ↗
• InjuryJun 23, 2021Retraction Problem; Failure to Form Staple; Retraction Problem; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE, THE ENDOWRIST STAPLER 45 WITH A WHITE VASCULAR RELOAD INSTALLED WAS FIRED ACROSS AN ARTERY WHEN THE BLADE BECAME EXPOSED AND NO STAPLES WERE FIRED. THE ARTERY WAS NOT SEALED, AND THE SURGEON USED A LARGE CLIP APPLIER TO CLIP THE ARTERY. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH CLINICAL SALES REPRESENTATIVE (CSR) WHO SPOKE TO SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THERE WAS NO INJURY TO THE PATIENT INVOLVED. THERE WERE ALSO NO STAPLES DEPLOYED DURING THE INCIDENT. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12047326 ↗
• InjuryMar 7, 2021Misfire; Misfire

  ON 02/09/2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MEDWATCH REPORT MW5098922 STATING: "A (B) (6) YEAR-OLD MALE PATIENT, UNDERGOING ROBOTIC ASSISTED TOTAL ABDOMINAL COLECTOMY, DURING PROCEDURE, THE WHITE VASCULAR LOAD MISFIRED OVER THE COLIC ARTERY TO THE SIGMOID COLON. THE STAPLER LOAD PARTIAL FIRED AND CUT. THERE WAS A SMALL AMOUNT OF BLEEDING FROM THE VESSEL. SURGEON PLACED A CLIP ON VESSEL. INTUITIVE DA VINCI XI SURGICAL SYSTEM ENDOWRIST STAPLER 44MM RELOAD REFERENCE # 48645W, LOT # M90200831. PROCEDURE NAME: ABDOMINAL COLECTOMY." INTUITIVE SURGICAL, INC. (ISI) HAS REACHED OUT TO THE CUSTOMER MULTIPLE TIMES TO OBTAIN ADDITIONAL INFORMATION. CORRECTED PATIENT-RELATED INFORMATION WAS PROVIDED, BUT NO OTHER ADDITIONAL DETAILS RELATED TO THE EVENT HAVE BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11429649 ↗
• MalfunctionJan 20, 2021Misfire

  A (B)(6) YEAR-OLD MALE PATIENT, UNDERGOING ROBOTIC ASSISTED TOTAL ABDOMINAL COLECTOMY. DURING PROCEDURE, THE WHITE VASCULAR LOAD MISFIRED OVER THE COLIC ARTERY TO THE SIGMOID COLON. THE STAPLER LOAD PARTIAL FIRED AND CUT. THERE WAS A SMALL AMOUNT OF BLEEDING FROM THE VESSEL. SURGEON PLACED A CLIP ON VESSEL. INTUITIVE DAVINCI XI SURGICAL SYSTEMS ENDOWRIST STAPLER 44MM RELOAD REFERENCE # 48645W, LOT # M90200831. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Blood Loss

  MAUDE report 11207517 ↗