Sureform 48230MRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00886874121931), received between Jun 17, 2022 and Nov 7, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Mar 11, 2026Open, Classified

   Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

   Z-1855-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. Oct 7, 2022Open, Classified

   Potential staple deployment failure and device fragment generation

   Z-0340-2023 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionNov 7, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED WEDGE TO COMPLETION LOBECTOMY SURGICAL PROCEDURE, THE SUREFORM 30 GRAY RELOAD BENT AND BROKE OFF. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO INSTRUMENT COLLISION DURING THE PROCEDURE. THE ISSUE OCCURRED WHILE THE RELOAD WAS BEING INSTALLED. THERE WAS NO FRAGMENT FALL INTO THE PATIENT AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494232 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOWRIST 30 GRAY RELOAD CAME APART WHEN THE YELLOW GUARD WAS REMOVED. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900998 ↗
• MalfunctionAug 18, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAW OF THE SUREFORM CURVED-TIP STAPLER 30 INSTRUMENT WAS MISALIGNED. USE OF THE INSTRUMENT WAS DISCONTINUED, AND IT WAS REPLACED TO THE BACKUP. NO FRAGMENT FELL INTO THE PATIENT. THE CUSTOMER COMPLETED THE PROCEDURE, AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834830 ↗
• MalfunctionAug 11, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 30 GRAY RELOAD COULD NOT BE REMOVED NORMALLY. THE USER WAS COMPLETING THE PROCEDURE AS PLANNED USING A BACKUP SUREFORM 30 GRAY RELOAD WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779440 ↗
• MalfunctionAug 2, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE ENDOWRIST 30 STAPLER GRAY RELOAD DISENGAGED FROM THE INSTALLATION TOOL PRIOR TO INSTALLING THE RELOAD ONTO THE RELOAD CHANNEL. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22694396 ↗
• MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ENDOWRIST 30 GRAY STAPLER RELOAD FELL OFF THE APPLICATOR BEFORE LOADING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. ON 06/09/2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE REPORT (B)(4) STATING: RELOAD FELL OFF APPLICATOR BEFORE LOADING. A NEW STAPLE LOAD OPENED TO COMPLETE THE PROCEDURE. RMA# [REDACTED]. INTUITIVE SURGICAL INC., (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER MENTIONED THAT THERE WAS NO PATIENT INJURY. THE STAPLES AND FRAGMENT(S) FROM RETURNED ACCESSORY DID NOT FALL INTO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22464231 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE STAPLER 30 GRAY RELOAD WAS BROKEN INTO PIECES. IT IS UNKNOWN IF A FRAGMENT FELL INTO THE PATIENT. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323522 ↗
• MalfunctionNov 5, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE RELOAD, STAPLER 30 TIP WAS FLIMSY AND BENT WHEN INSTALLING. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT INJURY REPORTED. FOLLOW-UP WAS ATTEMPTED TO REQUEST ADDITIONAL INFORMATION RELATED TO THE EVENT. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15741030 ↗
• MalfunctionNov 3, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THORACIC PROCEDURE, THE GREY RELOAD WAS DIFFICULT TO INSTALL. THE TIPS WERE FLIMSY AND WOULD BEND DURING INSTALLATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15721245 ↗
• InjuryOct 7, 2022Misfire; Detachment of Device or Device Component; Misfire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, WHEN THE CUSTOMER FIRED THE 8 MM SUREFORM 30 STAPLER WITH A GRAY RELOAD, THE STAPLE LINE DID NOT LAY DOWN AND THE STAPLER ¿KNIFE¿ FELL INSIDE THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE FRAGMENT IN THE SAME PROCEDURE WITH A BACKUP INSTRUMENT. THE CUSTOMER COMPLETED THE CASE WITH A SUREFORM 45 STAPLER. THE CUSTOMER DISCARDED THE STAPLER AND WOULD RETURN THE RELOAD ONLY. THE FRAGMENT DID NOT FALL INTO THE PATIENT DURING AN INSTRUMENT COLLISION. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION : THE ISSUE OCCURRED ON THE FIRST STAPLER FIRE OF THE PROCEDURE. THE SURGEON WAS FIRING ON THE SEGMENT BRANCH OF THE PULMONARY VEIN. THE STAPLER CLAMPED NORMALLY AND FIRED. THE GREY RELOAD ONLY FIRED ONE SIDE OF THE STAPLE LINE. THE SIDE THAT FIRED WAS COMPLETED WITHOUT ANY MISSING OR MALFORMED STAPLES. NONE OF THE STAPLES ON THE OTHER SIDE FIRED AT ALL. THERE WERE NO OBSTRUCTIONS, AND THE TISSUE WAS IN NORMAL CONDITION. THE STAPLE LINE WAS LEFT OPEN, AND THE PATIENT LOST 50CC OF BLOOD IN 2 SECONDS FROM THE SPECIMEN SIDE. TO ADDRESS THE BLEEDING, THE

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 15567303 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY RIGHT UPPER LOBECTOMY PROCEDURE, THE 8MM CURVED-TIP SUREFORM 30 STAPLER INSTRUMENT FIRED A GREY SUREFORM 30 RELOAD ON THE PULMONARY ARTERY AND THE STAPLE LINE OOZED SOME BLOOD. THE SURGEON REPORTEDLY DID NOT PERFORM ANY INTERVENTION DUE TO THIS EVENT AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE SURGEON SAID THE OOZING FROM THE STAPLE LINE WAS TYPICAL AND EXPECTED. THE SURGEON EXPLAINED THAT BLEEDING NORMALLY OCCURS WITH STAPLERS ON SMALL BLOOD VESSELS. THE SURGEON SAID THEY WOULD HAVE NORMALLY DIVIDED THIS VESSEL WITH ENERGY APPLICATION, BUT DECIDED TO USE THE 8MM CURVED-TIP SUREFORM 30 STAPLER WITH A GREY SUREFORM 30 RELOAD SINCE THEY WERE TESTING THIS DEVICE. THE SURGEON CLARIFIED THAT THE STAPLER INSTRUMENT AND RELOAD USED DURING THIS FIRE WORKED WELL AND THAT THEY DID NOT PERFORM ANY ACTIONS TO RESOLVE THE OOZING. THE SURGEON SAID THIS EVENT HAD NO IMPACT OF THE PROCEDURE OUTCOME NOR THE PATIENT OUTCOME. THE PATIENT WAS NOT REPORTEDLY HOSPITALIZED LONGER THAN THEY WERE EXPECTED TO, AND HA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14735375 ↗