FENIX FXS-[19]Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855106005523), received between Oct 28, 2016 and Nov 22, 2016 — classified as 2 injuries.

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.

• InjuryNov 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED A PERFORATION OF THE VAGINAL WALL DURING IMPLANT WHICH WAS STILL PRESENT AT FOLLOW UP VISIT LEADING TO FENIX DEVICE EXPLANT. THE FENIX DEVICE WAS USED AS PART OF THE SURGICAL PROCEDURE. -SURGICAL PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2016 THAT INCLUDED A POSTERIOR PERFORATION OF THE VAGINAL WALL DURING DISSECTION WHICH WAS SUTURED SHUT BEFORE THE DEVICE IMPLANT. -A FOLLOW UP VISIT NOTED THE DEVICE PROTRUDED THROUGH THE POSTERIOR VAGINAL WALL AT THE SITE OF THE SUTURE REPAIR AND AN UNEVENTFUL DEVICE EXPLANT OCCURRED ON (B)(6) 2016. -DEVICE WAS FOUND IN CORRECT POSITION/GEOMETRY AT THE TIME OF EXPLANT.

  Patient problems: Incontinence; Perforation; Wound Dehiscence

  MAUDE report 6123053 ↗
• InjuryOct 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED A PAIN AND WOUND DEHISCENCE LEADING TO FENIX DEVICE EXPLANT. THE FENIX DEVICE WAS USED AS PART OF THE SURGICAL PROCEDURE. SURGICAL PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2016. PATIENT WAS MONITORED FOR PAIN AND PROPHYLACTICALLY TREATED WITH ANTIBIOTICS. PATIENT RECEIVED IV ANTIBIOTICS 13 DAYS AFTER IMPLANT AND PATIENT REPORTED SYMPTOMS OF CONSTIPATION AND PAIN. DEVICE EXPLANT THROUGH SURGICAL SITE ON (B)(6) 2016 DUE TO PAIN AND WOULD DEHISCENCE. PHYSICIAN REPORTED THAT DURING DEVICE EXPLANT THE DEVICE GOT HUNG UP ON A LIGAMENT. A CLAMP WAS APPLIED TO EACH END OF THE CUT DEVICE AND A "GREAT DEAL OF FORCE" WAS APPLIED; ENOUGH TO BREAK A DEVICE CONNECTING WIRE. DEVICE WAS FOUND IN THE CORRECT POSITION AT TIME OF EXPLANT. PATIENT IS RECOVERING WELL.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 6064941 ↗