EndoWrist SP 430152Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00886874123461), received between Sep 9, 2025 and Jun 4, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY - RADICAL EXTRAPERITONEAL W/ LYMPHADENECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS BROKEN. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25401287 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD A CHIP AT THE TIP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EXACT TIME THE DAMAGE OCCURRED IS UNKNOWN, AS IT WAS ONLY NOTICED AFTER THE ITEM WAS SENT TO THE CENTRAL STERILE DEPARTMENT. THERE HAVE BEEN NO REPORTS OF FRAGMENTS FALLING, AND NO FRAGMENTS HAVE BEEN FOUND OR REPORTED. ADDITIONALLY, THERE HAVE BEEN NO COMPLICATIONS REPORTED, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL. FROM MY RECOLLECTION, THE DAMAGE WAS A VERY SMALL CRACK, BUT I DO NOT REMEMBER IF ANYTHING WAS MISSING. THERE ARE NO PHOTOGRAPHS OR IMAGES AVAILABLE TO PROVIDE FURTHER DETAIL.

  Patient problems: Insufficient Information

  MAUDE report 25224336 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SP MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS BROKEN IN THE JOINT, AND THE PLASTIC PART OF THE JOINT FELL OFF DURING THE RETURN PROCESS. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157267 ↗
• MalfunctionApr 7, 2026Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811353 ↗
• MalfunctionApr 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED PEDIATRIC PYELOPLASTY SURGICAL PROCEDURE, SP MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD MISALIGNED JAWS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24773091 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT'S TIP BROKE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24707016 ↗
• InjuryMar 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP FELL OFF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT DURING DISSECTION. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND SHOWED NO INITIAL DAMAGE. DURING A DISSECTING TASK, A FRAGMENT FELL INSIDE THE PATIENT DUE TO A COLLISION WITH ANOTHER INSTRUMENT. THE CAUSE OF THE BREAKAGE WAS UNKNOWN, BUT THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE, AND ALL FRAGMENTS WERE VISUALLY CONFIRMED AS RETRIEVED. DURING FINAL REMOVAL, THE WRIST WAS STRAIGHTENED AND THERE WAS NO RESISTANCE FELT; THERE WAS DAMAGE TO THE INSTRUMENT AND CANNULA. THERE WAS NO PATIENT INJURY, AND NO ADDITIONAL SURGICAL PROCEDURES OR POST-OPERATIVE TESTS WERE REQUIRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND THE INSTRUMENT IS AVAILABLE FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544217 ↗
• MalfunctionMar 6, 2026Arcing

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL TRANSVESICAL PROSTATECTOMY SURGICAL PROCEDURE, THE SURGEON OBSERVED ARCING WHEN CAUTERY WAS APPLIED CLOSE TO THE CAMERA, CAUSING THE CAMERA IMAGE TO INTERMITTENTLY CUT IN AND OUT. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE TSE COULD NOT FIND ANY RELATED ERRORS IN THE LOGS. THE TSE RECOMMENDED MARKING THE CAMERA AND ENSURING THE SHEATH WAS NOT DAMAGED. IF THE ISSUE PERSISTED, THE TSE SUGGESTED RETURNING THE CAMERA. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24538914 ↗
• InjuryFeb 7, 2026Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24286115 ↗
• MalfunctionOct 23, 2025Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 6MM MARYLAND BIPOLAR FORCEPS JAWS WOULD NOT CLOSE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364714 ↗
• MalfunctionSep 9, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT MOVED IN THE OPPOSITE DIRECTION OF THE SURGEON'S COMMAND. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WERE NO REPORTS OF PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH A BACKUP SIMILAR INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 23008169 ↗