Senhance X0007005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815440020026), received between Mar 17, 2021 and Nov 19, 2021 — classified as 1 injury, 1 malfunction.

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

• MalfunctionNov 19, 2021Mechanical Problem; Mechanical Problem

  THE EVENT OCCURRED ON (B)(6) 2021 AT (B)(6) HOSPITAL, WHICH IS LOCATED IN THE (B)(6). THE EVENT WAS REPORTED TO THE COMPANY BY THE ASENSUS AREA SALES MANAGER. THE EVENT INVOLVED FOUR SENHANCE MANIPULATOR ARMS (X9000005, UDI: (B)(4), SERIAL NUMBERS (B)(4)) AND JOHAN GRASPER 15 MM Ø 5 MM X 310 MM (PN: X0007005, UDI: (B)(4), LOT: 1845171). THE TIME OF OCCURENCE WAS DURING A SURGICAL CASE AND THE SURGICAL PROCEDURE WAS FOR A MALROTATION VOLVUS WITH APPENDECTOMY. THE PATIENT WAS A (B)(6) CAUCASIAN MALE WITH WEIGHT OF (B)(6) KG AND BMI OF 16.6. THE SENHANCE SYSTEM AND ASSOCIATED DEVICES ARE NOT INDICATED FOR PEDIATRIC USE IN THE US (K202166). IT WAS INITIALLY REPORTED BY THE SURGEON THAT "DURING SURGERY THEY NOTICED THAT THE BOWEL WAS IMPACTED BY THE GRASPING FORCE OF THE JOHAN GRASPER. HOWEVER, THE SEROSA OF THE BOWEL WAS VISIBLY DAMAGED BY THE JOHAN GRASPERS. THE SURGICAL TEAM DECIDED TO CHANGE THEIR APPROACH OF THE BOWEL DUE TO THIS VISIBLE TRAUMATIC EFFECT THAT WAS INDUCED BY THE USE OF THE JOHAN GRASPER. SURGICAL TEAM AVOIDED MANIPULATING THE BOWEL AS MUCH AS POSSIBLE OR MANIPULATED IT AS QUICKLY AS POSSIBLE. THERE WAS NO DELAY TO THE SURGICAL CASE." IT WAS LATER REPORTED THAT, DUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848094 ↗
• InjuryMar 17, 2021Mechanical Problem; Mechanical Problem

  THE EVENT WAS REPORTED AS A COMPLAINT ON (B)(6) 2021. THE EVENT OCCURRED AT (B)(6) HOSPITAL, WHICH IS LOCATED IN THE (B)(6). THE EVENT INVOLVED TWO SENHANCE MANIPULATOR ARMS (X9000005, UDI: (B)(4), SERIAL NUMBERS (B)(4)) AND TWO JOHAN GRASPERS 15 MM Ø 5 MM X 310 MM (X0007005, UDI: (B)(4), LOT: 1845171). THE TIME OF OCCURRENCE WAS DURING A SURGICAL CASE AND THE SURGICAL PROCEDURE WAS FOR TREATMENT OF MALROTATION VOLVULUS. THE PATIENT WAS A (B)(6) CAUCASIAN FEMALE WITH WEIGHT OF (B)(6) AND BMI OF 29.2. THE SENHANCE SYSTEM AND ASSOCIATED DEVICES ARE NOT INDICATED FOR PEDIATRIC USE IN THE US. AS INITIALLY REPORTED BY THE COMPLAINANT, DURING THE CASE THE SMALL INTESTINE WAS PERFORATED 2 TIMES WITH THE JOHAN GRASPER. WHEN HOLDING THE TISSUE WITH THE GRASPER, THE TISSUE TURNED WHITE DUE TO THE GRASPING FORCE. AFTER STITCHING BOTH PERFORATIONS, THE SURGEON COULD CONTINUE WITH THE CASE. THE USE OF TWO JOHAN GRASPING FORCEPS CAUSED HEMATOMA OF THE SEROSA AND EVENTUALLY 2 PERFORATIONS OF THE SMALL INTESTINE. THE FOOTPRINT OF EVERY BITE WAS VISIBLE ON THE TISSUE. THE PROCEDURAL DELAY WAS LESS THAN 15 MINS. ADDITIONAL QUESTIONS WERE POSED TO FURTHER INVESTIGATE THE IMPACT ON THE PATIENT. THERE

  Patient problems: Bowel Perforation

  MAUDE report 11507355 ↗