Solyx™ Blue M0068507010Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 08714729961901), received between Feb 13, 2019 and Sep 18, 2026 — classified as 27 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (12 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820684 ↗
• MalfunctionMar 16, 2026Premature Activation; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SOLYX BLUE SIS SYSTEM DEVICE WAS USED DURING A PLACEMENT OF MIDURETHRAL SLING WITH CYSTOSCOPY PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, WHILE PLACING THE SLING ON THE PATIENTS LEFT SIDE, THE SURGEON ATTEMPTED TO WITHDRAW THE DELIVERY DEVICE TO REPOSITION THE TRAJECTORY. DURING THIS MANEUVER, THE MESH RELEASED FROM THE DEVICE WITHOUT RELEASING WITH THE KNOB. WHEN THE SURGEON ATTEMPTED TO REMOVE THE MESH, THE MESH CARRIER DETACHED FROM THE MESH AND WAS LEFT INSIDE THE PATIENT. NO ATTEMPTS WERE MADE TO RETRIEVE THE RETAINED MESH CARRIER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24612026 ↗
• MalfunctionMar 13, 2026Positioning Failure; Material Deformation

  IT WAS REPORTED THAT A SOLYX BLUE SIS SYSTEM DEVICE WAS USED DURING A MID-URETHRAL SLING PROCEDURE ON (B)(6) 2026. DURING THE INSERTION, THE PHYSICIAN ATTEMPTED TO PASS THE FIRST SIDE OF THE SOLYX SLING. THE MESH CARRIER CAUGHT ON THE MESH AND FAILED TO DEPLOY PROPERLY. AS A RESULT, THE MESH BECAME EXCESSIVELY STRETCHED, AND THE SLING COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SOLYX SLING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594197 ↗
• MalfunctionMar 6, 2026Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE MIDURETHRAL SLING PROCEDURE USING A SOLYX DEVICE, THE DEVICE MAY HAVE HIT A BONE AND BECOME BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537004 ↗
• MalfunctionFeb 23, 2026Nonstandard Device; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE USING A SOLYX BLUE SIS SYSTEM DEVICE, THE MESH DETACHED FROM THE ANCHOR IN THE SLING. THE PROCEDURE WAS COMPLETED USING ADVANTAGE FIT BLUE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT THE DELIVERY DEVICE TIP WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415734 ↗
• InjuryJan 16, 2026Positioning Failure; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A MID-URETHRAL SLING PROCEDURE USING A SOLYX BLUE DEVICE, PLACEMENT OF THE DEVICE ON THE PATIENT'S RIGHT SIDE WAS COMPLETED WITHOUT ISSUE, BUT THE PHYSICIAN ENCOUNTERED DIFFICULTY WITH THE PATIENT'S ANATOMY WHILE ATTEMPTING LEFT-SIDED PLACEMENT, RESULTING IN CONTACT BETWEEN THE TROCAR TIP AND THE PELVIC BONE RATHER THAN ADVANCEMENT THROUGH THE OBTURATOR MUSCLE. CONTINUED PRESSURE AGAINST THE BONE CAUSED THE NEEDLE TIP TO BEND. THE TROCAR WAS WITHDRAWN, AND ADDITIONAL ATTEMPTS WERE MADE TO IDENTIFY THE CORRECT PLANE OF PLACEMENT; HOWEVER, THE BENT NEEDLE TIP WAS SUBSEQUENTLY IDENTIFIED. A SECOND SOLYX BLUE DEVICE WAS OPENED, AND A NEW DELIVERY DEVICE FROM THAT KIT WAS USED TO COMPLETE THE LEFT-SIDED PLACEMENT OF THE ORIGINAL SOLYX BLUE MESH. FOLLOWING THE PROCEDURE, THE PATIENT HAS BEEN FEELING PAIN AND DISCOMFORT.

  Patient problems: Discomfort; Pain

  MAUDE report 24094934 ↗
• MalfunctionJan 13, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SOLYX DEVICE WAS DIFFICULT TO ADVANCE THROUGH THE PATIENT'S TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052588 ↗
• MalfunctionJan 7, 2026Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE SOLYX DEVICE THROUGH THE PATIENT'S TISSUE, WHICH LED TO THE MESH DEFORMING. ANOTHER SOLYX DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED FOLLOWING THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989037 ↗
• InjuryNov 14, 2025Difficult to Advance; Difficult to Advance

  It was reported that during the procedure, the obturator was not properly aligned, resulting in a vaginal wall perforation during sling manipulation. The implanted mesh was immediately removed, and a new Solyx sling was reinserted to complete the procedure. No further patient complications were reported following the incident.

  Patient problems: Perforation

  MAUDE report 23560989 ↗
• MalfunctionOct 28, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE MESH CARRIER PREMATURELY DEPLOYED FROM THE SHAFT TIP, RESULTING IN DIFFICULTY TENSIONING THE MESH PROPERLY. UPON REMOVAL, THE MESH WAS OBSERVED TO BE STRETCHED AND DEFORMED, LEADING THE PHYSICIAN TO DISCONTINUE ITS USE. THE PHYSICIAN SUBSEQUENTLY PERFORMED A RETROPUBIC SLING PROCEDURE USING AN ADVANTAGE FIT BLUE SYSTEM TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408026 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF A SOLYX? BLUE DEVICE, THE PATIENT EXPERIENCED URINARY RETENTION. AS THE RETENTION DID NOT RESOLVE, THE PHYSICIAN DECIDED TO LOOSEN THE SLING ON (B)(6) 2025. THE SLING WAS SUCCESSFULLY ADJUSTED, AFTER WHICH THE PATIENT PASSED THE VOIDING TRIAL AND IS CURRENTLY DOING WELL.

  Patient problems: Urinary Retention

  MAUDE report 23030593 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SACRAL COLPOPEXY PROCEDURE, THE PATIENT INITIALLY PASSED THE VOIDING TRIAL. HOWEVER, A FEW DAYS LATER, THE PATIENT RETURNED WITH A HIGH POST-VOID RESIDUAL (PVR). A FOLEY WAS REINSERTED FOR A FEW DAYS; HOWEVER, THE PATIENT DID NOT PASS THE VOIDING TRIAL AGAIN. AS A RESULT, THE PHYSICIAN DECIDED TO CUT THE SLING. DURING THE REVISION CASE, THE SLING WAS EASILY LOCATED AND CUT. THE PATIENT COULD VOID NORMALLY FOLLOWING THE PROCEDURE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Retention

  MAUDE report 22903134 ↗
• MalfunctionJul 16, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A SLING PROCEDURE USING A SOLYX BLUE DEVICE, THE NEEDLE TIP WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523236 ↗
• MalfunctionMar 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A MID-URETHRAL SLING PROCEDURE USING A SOLYX BLUE DEVICE, THE NEEDLE TIP WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21626323 ↗
• MalfunctionMar 6, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE USING A SOLYX BLUE DEVICE, THE DEVICE HAD DIFFICULTY ADVANCING. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21538232 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME AFTER IMPLANTATION, THE PATIENT PASSED HER VOIDING TRAIL IN THE POST ANESTHESIA CARE UNIT (PACU) AND WAS SENT HOME. HOWEVER, A FEW DAYS LATER, SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), WITH 1700 CCS IN HER BLADDER. SHE BECAME HYPONATREMIC AND STAYED IN THE ICU UNTIL HER SODIUM WOULD GET UNDER CONTROL. ACCORDING TO THE PHYSICIAN, SHE HAS HAD A HISTORY OF SODIUM IMBALANCE WHEREIN THERE WAS A HYPOTHESIS BY THE ANESTHESIOLOGIST THAT THE ISSUE WAS CAUSED BY DRUG INTERACTION, BUT IT STILL SEEMS TO BE UNCLEAR. THE PATIENT WAS SENT HOME AND TAUGHT TO CLEAN INTERMITTENT CATHETERIZATION (CIC); HOWEVER, SHE WAS RECENTLY RE-ADMITTED TO THE HOSPITAL, AND HER CARE IS ONGOING.

  Patient problems: Electrolyte Imbalance; Urinary Retention

  MAUDE report 20409194 ↗
• MalfunctionOct 2, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A MID-URETHRAL SLING PROCEDURE, THE SLING WAS NOT TIGHT ENOUGH AND COULD NOT BE RE-TENSIONED DUE TO THE ANCHOR THAT DID NOT SEAT CORRECTLY. THE SURGEON THEN HAD TO ABORT THE PROCEDURE AS THERE WERE NO MORE SOLYX OR OTHER MINI-SLINGS IN THE HOSPITAL. FURTHERMORE, THE SPACE UNDER THE URETHRA WAS TOO NARROW FOR THE WIDTH OF A RETROPUBIC SLING. THE VAGINAL MUCOSA WAS THIN, AND TUNNELS WERE TOO SMALL, WHICH WOULD MAKE IT HARD TO GET THE RETROPUBIC SLING TO FIT IN THE SPACE. THE SOLYX MESH WAS THEN REMOVED, LEAVING THE MESH CARRIERS IN PLACE BILATERALLY. THIS EVENT IS BEING REPORTED FOR AN ABORTED OR CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351853 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SOLYX MID URETHRAL SLING IMPLANT PROCEDURE ON (B)(6) 2020, DURING THE SAME SURGERY AN ANTERIOR AND POSTERIOR VAGINAL REPAIR, ENTEROCELE REPAIR AND SACROSPINOUS VAULT SUSPENSION WERE ALSO PERFORMED. ON (B)(6) 2022, THE PATIENT PRESENTED PELVIC FLOOR RELAXATION, PELVIC PRESSURE, PAIN, DYSPAREUNIA, AND URINARY INCONTINENCE. ANOTHER SOLYX MID URETHRAL SLING WAS IMPLANTED. ADDITIONALLY, DURING THE PROCEDURE ANTERIOR AND POSTERIOR VAGINAL REPAIR, ENTEROCELE REPAIR AND SACROSPINOUS VAULT SUSPENSION PROCEDURE WERE PERFORMED AGAIN. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS AWOKEN FROM GENERAL ANESTHESIA, WAS TAKEN TO THE RECOVERY IN STABLE CONDITION. ON (B)(6) 2024, THE PATIENT PRESENTED CHRONIC BLADDER PAIN, PAINFUL URGENCY, BLADDER SPASMS, INCONTINENCE AND A FEELING OF INCOMPLETE BLADDER EMPTYING. DURING PALPATION, PELVIC PAIN WAS ALSO NOTED; HOWEVER, THE PATIENT DID NOT PRESENT ANY MESH EXPOSURE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH PELVIC TRIGGER POINT INJECTIONS WERE ADMINISTERED TO AID WITH THE CHRONIC PAIN AND PELVIC HYPOTONICITY. THE SOLUTION CONSISTED OF BUPIVACAINE WITH EPINEPHRINE AND TRIAMCINOLONE. ADDITIONALLY, THE EXIS

  Patient problems: Anxiety; Blurred Vision; Bruise/Contusion; Constipation; Cough; Cramp(s) /Muscle Spasm(s); Dehydration; Dyspareunia; Fatigue; Headache; Hypersensitivity/Allergic reaction; Insufficient Information; Itching Sensation; Micturition Urgency; Muscle Weakness/Atrophy; Neck Pain; Pain; Prolapse; Sexual Dysfunction; Sleep Dysfunction; Unspecified Kidney or Urinary Problem; Unspecified Musculoskeletal problem; Unspecified Tissue Injury; Urinary Incontinence; Urinary Retention; Weight Changes

  MAUDE report 19756352 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, SOMETIME AFTER IMPLANTATION OF THE SOLYX SINGLE INCISION SLING SYSTEM, THE PATIENT EXPERIENCED RIGHT GROIN PAIN IN HER PELVIS. THE PAIN RADIATED THROUGHOUT WHICH CAUSED PELVIC FLOOR SPASMS. THE PAIN SUBSIDED AFTER BEING TREATED WITH GABAPENTIN. THE PATIENT WILL FOLLOW UP WITH THE PHYSICIAN AFTER A WEEK, AND IF THE PAIN PERSISTS, A TRIGGER POINT INJECTION IS RECOMMENDED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain

  MAUDE report 19756160 ↗
• MalfunctionJul 1, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STRESS URINARY INCONTINENCE PROCEDURE USING A SOLYX SIS SYSTEM, THE SURGEON HAD DIFFICULTY LOADING THE DEVICE INTO THE TROCAR. THE DEVICE WAS EVENTUALLY PLACED BUT IT WOULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643849 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS USED DURING A MID-URETHRAL SLING PROCEDURE PERFORMED ON (B)(6) 2020, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. ON (B)(6) 2023, THE PATIENT UNDERWENT AN EXAM UNDER ANESTHESIA AND A REVISION OF THE MID URETHRAL SLING. IT WAS INDICATED THAT THE PATIENT HAD DEVELOPED MESH EXPOSURE IN THE MIDLINE URETHRA THAT WAS BOTHERING THE PATIENT AND HER PARTNER. DURING PROCEDURE A CYSTOURETHROSCOPY WAS PERFORMED, REVEALING NO EVIDENCE OF MESH IN THE URETHRA OR BLADDER. THE MESH WAS DISSECTED AWAY FROM THE UNDERLYING ELEMENTS OF THE PUBO-VESICO CERVICAL FASCIA. IT WAS NOTED THAT A SMALL PORTION OF MESH THAT WAS ALREADY INCORPORATED IN THE TISSUE WAS ALSO REMOVED. A SECOND CYSTOURETHROSCOPY WAS PERFORMED, CONFIRMING THERE WERE NO LESIONS TO THE BLADDER. ON (B)(6) 2023, THE PATIENT PRESENTED WITH RECURRING STRESS URINARY INCONTINENCE LEADING TO A ROBOTIC-ASSISTED LAPAROSCOPIC COLPO SUSPENSION (BURCH PROCEDURE). DURING THE PROCEDURE, ADHESIONS FROM THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL WERE NOTED. THE BLADDER HAD LOSS OF SURGICAL PLANES SECONDARY TO THE ADHESIONS FROM THE PREVIOUS HYSTERECTOMY. CAREFUL LYSIS OF A

  Patient problems: Adhesion(s); Erosion; Urinary Incontinence

  MAUDE report 19033640 ↗
• InjuryDec 26, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS USED DURING A SOLYX IMPLANTATION OF FEMALE SLING PROCEDURE, PERFORMED ON (B)(6) 2023. DURING INSERTION, THE DEVICE WAS REPORTED TO BE FRACTURED/BROKEN. THE EVENT IS UNCLEAR AND ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. THE EVENT DESCRIPTION MAY SUGGEST THAT THE DELIVERY SYSTEM TIP WAS DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393002 ↗
• MalfunctionOct 26, 2023Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM DEVICE WAS USED DURING A STRESS URINARY INCONTINENCE (SUI) PROCEDURE PERFORMED ON (B)(6) 2023, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SLING GOT STUCK ON THE TROCAR ON ONE SIDE, WHICH MOST LIKELY SUGGESTS THAT THE MESH CARRIER FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER SOLYX BLUE SIS, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013189 ↗
• MalfunctionApr 21, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM DEVICE WAS OPENED DURING A MID-URETHRAL SLING PROCEDURE PERFORMED ON (B)(6) 2023, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. UPON OPENING THE DEVICE DURING THE PREPARATION, IT WAS NOTICED THAT THERE WAS A HAIR INSIDE THE STERILE POUCH. THERE WAS NO DAMAGE NOTED ON THE PACKAGING, AND THE STERILE SEALS WERE INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SOLYX SIS SYSTEM DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16787524 ↗
• MalfunctionMar 2, 2023Premature Activation; Difficult to Advance; Material Twisted/Bent; Premature Activation; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM DEVICE WAS USED DURING A MID-URETHRAL SLING PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. THIS WAS THE PHYSICIAN'S SECOND EVER SOLYX CASE AS THE FIRST ONE WAS ONLY TWO HOURS BEFORE THIS EVENT. DURING THE PROCEDURE, THE PHYSICIAN WAS EXPERIENCING DIFFICULTY ADVANCING THE TROCAR. THE INSERTION OF THE TROCAR WAS TOO SHALLOW, RESULTING IN THE TROCAR BEING PUSHED INTO THE INFERIOR PUBIC RAMUS. THE PHYSICIAN KEPT PUSHING AND WAITING FOR THE POP INTO THE OBTURATOR INTERNUS MUSCLE, BUT NEVER FELT THE POP BECAUSE SHE WASN'T IN THE RIGHT POSITION FOR THAT TO HAPPEN. THE FORCE APPLIED TO THE TROCAR WHEN PUSHING AGAINST THE BONE THEN CAUSED THE TROCAR TIP TO BEND. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE IN ORDER TO RE-ATTEMPT INSERTION, BUT THE MESH ANCHOR DETACHED FROM THE TROCAR (PREMATURELY DEPLOYED). THE MESH WAS THEN REMOVED LEAVING THE PLASTIC MESH ANCHORS IN PLACE. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER SOLYX SIS SYSTEM DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16471044 ↗