EndoWrist 41645BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874112816), received between Oct 9, 2020 and Jun 28, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Form Staple” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, WHEN THE CUSTOMER TRIED TO RESECT WITH THE STAPLER 45, INSTALLED WITH A BLUE CARTRIDGE, AN ERROR MESSAGE WAS RECEIVED. THE ENDOWRIST STAPLER 45 INSTRUMENT JAWS WAS STUCK ON TISSUE. A MESSAGE PROMPTING THE USER TO USE THE STAPLER RELEASE KIT (SRK) WAS DISPLAYED. THE CUSTOMER FOLLOWED THE INSTRUCTIONS TO USE THE SRK. THE CUSTOMER STATED THAT ANOTHER INSTRUMENT WAS INSTALLED AND FIRED TO COMPLETE THE PROCEDURE. THE SURGEON ACKNOWLEDGED THAT THE USE OF THE BLUE RELOAD MAY HAVE NOT BEEN APPROPRIATE SINCE MULTIPLE CLAMPS WERE REQUIRED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO ADDITIONAL ISSUES. ON 24-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE NOTED. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS, BUT THE SURGEON HAD TO CLAMP FOUR (4) OR FIVE (5) TIMES IN ORDER FOR THE INSTRUMENT TO FIRE. THE SURGEON ACKNOWLEDGED THAT TISSUE THICKNESS MAY HAVE BEEN INAPPROPRIATE FOR THE BL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14848908 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STAPLER 45 INSTRUMENT ¿LOCKED UP¿ DURING A DA VINCI-ASSISTED PROCEDURE. A BLUE STAPLER 45 RELOAD WAS INSTALLED ON THE DA VINCI SURGICAL SYSTEM. THE SITE WAS ABLE TO SUCCESSFULLY USE THE STAPLER RELEASE KEY (SRK) TO OPEN THE INSTRUMENT¿S JAWS. THE PROCEDURE WAS COMPLETED WITH A BACKUP ENDOGIA LAPAROSCOPIC INSTRUMENT AND THERE WAS NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME. ON 11-SEPT-2020, INTUITIVE SURGICAL, INC. (ISI), CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON STATED THAT HE HAD TWO ISSUES WITH THE STAPLER 45 INSTRUMENT. TISSUE WAS THICK AND THE STAPLER HAD PROBLEMS CLAMPING DOWN COMPLETELY. IT TOOK MORE THAN 10 MINUTES TO FINALLY FIRE THE FIRST TIME. THE FIRST ERROR OCCURRED DURING ONE OF THE UNCLAMPING SEQUENCES WHERE AN ERROR MESSAGE STATED BLADE WAS EXPOSED AND THE RELOAD WAS REPLACED. THE SURGEON STATED THAT HE WAS ABLE TO FIRE THE STAPLER WITH THE RELOAD. HOWEVER, HE STATED THAT HE WAS UNABLE TO COMPLETELY TRANSECT THE BOWEL AND, AS A RESULT, USED ANOTHER RELOAD. AT THAT TIME, THE SECOND ERROR OCCURRED. AS A RESULT, THE STAPLER RELEASE KEY WAS USED TO REMOVE THE STAPLER. THE SURGEON THEN USED AN ENDOGIA LAPAROS

  Patient problems: Failure to Anastomose

  MAUDE report 10654152 ↗