Senhance X0007177Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815440021894), received between Jan 6, 2023 and Mar 13, 2026 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionMar 13, 2026Detachment of Device or Device Component; Device Damaged by Another Device; Material Integrity Problem

  DATE OF INCIDENT: (B)(6) LOCATION: (B)(6), AUSTRIA DEVICE: MONOPOLAR L-HOOK INSTRUMENT (X0007177) NO ADVERSE EVENT OCCURRED TO A PATIENT OR USER. DURING A PEDIATRIC SURGICAL PROCEDURE INVOLVING A PEDIATRIC PATIENT (MALE, 172CM, 80KG) AT (B)(6), AUSTRIA, WHERE THE SENHANCE SURGICAL SYSTEM IS INSTALLED, THE 5 MM MONOPOLAR L-HOOK INSTRUMENT BROKE AT ITS DISTAL PART. THIS TYPE OF BREAKAGE IS CONSIDERED POTENTIALLY CRITICAL BECAUSE THE DISTAL PORTION OF THE INSTRUMENT IS RESPONSIBLE FOR TRANSMITTING ELECTRICAL ENERGY. BASED ON THE ONLY IMAGE OF THE DAMAGED INSTRUMENT, ITS CONDITION HAD THE POTENTIAL TO LEAD TO UNINTENDED ENERGY DISCHARGE OR SPARKING. HOWEVER, ACCORDING TO THE REPORT RECEIVED, NO ENERGY DISPERSION AND NO TISSUE DAMAGE WAS OBSERVED OR REPORTED DURING THE EVENT. THE INSTRUMENT DID NOT FALL INTO THE PATIENT. AND COMPLETED THE PROCEDURE WITHOUT DELAY OR REPORTED IMPACT BY TRANFERING TO TRADITIONAL LAPAROSCOPY. NO HARM OCCURRED AND NO ENERGY DISPERSION WAS REPORTED, HOWEVER IF THIS INCIDENT WERE TO RECUR THEN THE INSTRUMENT BREAKAGE HAS THE POTENTIAL TO CAUSE TISSUE DAMAGE DUE TO IF THE INSTRUMENT SLIPPED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591844 ↗
• MalfunctionNov 20, 2025Break; Material Fragmentation; Naturally Worn; Break; Material Fragmentation; Naturally Worn

  DATE OF INCIDENT: (B)(6) 2025. LOCATION: (B)(6). DEVICE: MONOPOLAR L-HOOK INSTRUMENT (X0007177). NO INJURY OCCURRED TO A PATIENT OR USER. DURING A PEDIATRIC SURGICAL PROCEDURE INVOLVING A 15-YEAR-OLD PATIENT AT (B)(6) HOSPITAL (B)(6), WHERE THE SENHANCE SURGICAL SYSTEM IS INSTALLED, THE 5 MM MONOPOLAR L-HOOK INSTRUMENT BROKE AT ITS DISTAL PART. THIS TYPE OF BREAKAGE IS CONSIDERED POTENTIALLY CRITICAL BECAUSE THE DISTAL PORTION OF THE INSTRUMENT IS RESPONSIBLE FOR TRANSMITTING ELECTRICAL ENERGY. BASED ON THE ONLY IMAGE OF THE DAMAGED INSTRUMENT, ITS CONDITION HAD THE POTENTIAL TO LEAD TO UNINTENDED ENERGY DISCHARGE OR SPARKING. HOWEVER, ACCORDING TO THE REPORT RECEIVED, NO ENERGY DISPERSION AND NO TISSUE DAMAGE WAS OBSERVED OR REPORTED DURING THE EVENT. THE RISK OF UNINTENDED ENERGY TRANSFER REMAINS A POSSIBILITY THAT REQUIRES VERIFICATION THROUGH THE ONGOING INVESTIGATION. THE SURGICAL TEAM SUCCESSFULLY AND SAFELY REMOVED THE BROKEN INSTRUMENT WITHOUT LEAVING ANY FRAGMENTS INSIDE THE PATIENT, REPLACED IT, AND COMPLETED THE PROCEDURE WITHOUT DELAY OR REPORTED IMPACT. NO HARM OCCURRED AND NO ENERGY DISPERSION WAS REPORTED, HOWEVER IF THIS INCIDENT WERE TO RECUR THEN THE INSTRUMENT BR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612530 ↗
• MalfunctionMay 8, 2025Break; Material Separation; Break; Material Separation

  DATE OF INCIDENT: (B)(6) 2025. LOCATION: (B)(6). DEVICE: MONOPOLAR L-HOOK INSTRUMENT (X0007177). NO INJURY OCCURRED TO A PATIENT OR USER. IT WAS REPORTED THAT DURING A ROBOTICALLY-ASSISTED LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, A MATERIAL SEPARATION OCCURRED INVOLVING A MONOPOLAR L-HOOK INSTRUMENT. WHILE THE ROBOTIC SURGICAL SYSTEM WAS MANEUVERING THE INSTRUMENT TO FACILITATE CONTINUED DISSECTION OF THE GALLBLADDER FROM THE LIVER BED, THE L-HOOK DETACHED FROM THE ADAPTER AND DESCENDED INTO THE PATIENT'S ABDOMEN WITHOUT DIRECT SURGEON COMMAND. SUBSEQUENT BEDSIDE EXAMINATION REVEALED THAT THE L-HOOK HAD SEPARATED FROM THE ADAPTER WHILE THE ADAPTER REMAINED AFFIXED TO THE MANIPULATOR ARM. THE DETACHED L-HOOK WAS OBSERVED SUSPENDED WITHIN THE TROCAR UNTIL MANUALLY AND FULLY RETRIEVED BY THE BEDSIDE ASSISTANT. EXAMINATION OF THE ABDOMINAL CAVITY INDICATED NO APPARENT CONTACT BETWEEN THE DETACHED L-HOOK AND ANY ANATOMICAL STRUCTURES. THE SURGICAL PROCEDURE EXPERIENCED A DELAY OF LESS THAN 15 MINUTES AS A RESULT OF THIS EVENT. THE ATTENDING SURGEON REPORTED NO CONCERNS REGARDING POTENTIAL TISSUE INJURY RELATED TO THE DEVICE MALFUNCTION. AN INVESTIGATION INTO THE CAUSE OF THE MATERIAL SEP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987574 ↗
• InjuryJan 6, 2023Use of Device Problem; Use of Device Problem

  THE EVENT WAS MADE AWARE ON 12/19/2023. THE EVENT OCCURRED AT (B)(6). AS INITIALLY REPORTED BY THE COMPLAINANT, ON THURSDAY, (B)(6) 2022, DOCTOR VISSCHERS, PERFORMED A FUNDOPLICATION ON A PEDIATRIC FEMALE PATIENT. THE PATIENT WAS DOING WELL AND WAS DISCHARGED ON FRIDAY, (B)(6) 2022. NO CHANGE TO THE SURGICAL APPROACH OR ADDITIONAL PORTS WERE NEEDED. ON SUNDAY, (B)(6) 2022 THE PATIENT WAS READMITTED TO THE HOSPITAL WITH PERSISTENT ABDOMINAL PAIN, WHICH REQUIRED A SECOND OPERATION. THE SURGEONS DIAGNOSED A PERFORATION OF THE WRAP, SURROUNDING THE ESOPHAGUS, DEEMED TO BE RELATED TO A THERMAL LESION AFFECTING THE VASA PREVIA, NAMELY THE BRANCHES OF SPLENIC ARTERY AND VEIN THAT RUN TO THE GREATER CURVATURE OF THE STOMACH. THE PATIENT WAS THEREFORE TREATED WITH ANTIBIOTICS AND 2 DRAINS WERE APPLIED ON THE STOMACH AND SMALL PELVIS. SUBSEQUENT ECHOGRAPHY AND GASTROSCOPY REVEALED NO INDICATION OF A PERSISTENT PERFORATION. ON FRIDAY,(B)(6) 2022 THE PATIENT WAS DOING WELL AND WAS REPORTED TO BE LIVELY AND ACTIVE. THE SURGEON AND THE COMPLAINANT REPORTED THAT THE ISSUE WAS NOT RELATED TO THE USE OF THE SENHANCE SYSTEM USED IN THE FIRST PROCEDURE PERFORMED BUT RATHER INDUCED BY ELECTROCAUTERY.

  Patient problems: Perforation of Esophagus

  MAUDE report 16113208 ↗