STRATAFIX SXPP1B450Recalls & reported problems

Summary

The FDA's MAUDE database contains 206 adverse event reports that list this exact device (DI 10705031236219), received between Feb 13, 2018 and Sep 17, 2026 — classified as 35 injuries, 171 malfunctions.

The most frequently reported specific device problem is “Material Separation” (82 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 206 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  It was reported that a patient underwent a robotic hysterectomy procedure on an unknown date and barbed suture was used. during a robotic hysterectomy procedure, several sutures broke during use. The issue reportedly occurred three times on the same day (Tuesday) 2 x in the same patient and other for different patient. It also occurred on at least one occasion during the previous week. The reporter was unsure whether the issue may have occurred one to two additional times that day. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803055 ↗
• MalfunctionSep 17, 2026Break

  It was reported that a patient underwent a robotic hysterectomy procedure on an unknown date and barbed suture was used. during a robotic hysterectomy procedure, several sutures broke during use. The issue reportedly occurred three times on the same day (Tuesday) 2 x in the same patient and other for different patient. It also occurred on at least one occasion during the previous week. The reporter was unsure whether the issue may have occurred one to two additional times that day. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802877 ↗
• MalfunctionSep 17, 2026Break

  It was reported that a patient underwent a robotic hysterectomy procedure on an unknown date and barbed suture was used. during a robotic hysterectomy procedure, several sutures broke during use. The issue reportedly occurred three times on the same day (Tuesday) 2 x in the same patient and other for different patient. It also occurred on at least one occasion during the previous week. The reporter was unsure whether the issue may have occurred one to two additional times that day. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802779 ↗
• MalfunctionJun 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT ON (B)(6) 2026 MULTIPLE STRANDS OF STRATAFIX SPIRAL NEEDLES SEPARATED AT THE SWAGE DURING TWO DIFFERENT ROBOTIC HYSTERECTOMIES WITH SURGEON. A TOTAL OF 7 SUTURE STRANDS, 3 DURING ONE PROCEDURE, 4 DURING ANOTHER, HAD THE NEEDLES EASILY POP-OFF. THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING ADDITIONAL STRATAFIX SUTURES AND THERE WAS NO ADVERSE PATIENT IMPACT. STAFF DID NOT RETAIN ANY OF THE BROKEN SUTURES OR NEEDLES, NOR DID THEY DOCUMENT THE LOT. NO DELAY OR PATIENT HARM WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503640 ↗
• MalfunctionJun 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT ON (B)(6) 2026 MULTIPLE STRANDS OF STRATAFIX SPIRAL NEEDLES SEPARATED AT THE SWAGE DURING TWO DIFFERENT ROBOTIC HYSTERECTOMIES WITH SURGEON. A TOTAL OF 7 SUTURE STRANDS, 3 DURING ONE PROCEDURE, 4 DURING ANOTHER, HAD THE NEEDLES EASILY POP-OFF. THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING ADDITIONAL STRATAFIX SUTURES AND THERE WAS NO ADVERSE PATIENT IMPACT. STAFF DID NOT RETAIN ANY OF THE BROKEN SUTURES OR NEEDLES, NOR DID THEY DOCUMENT THE LOT. NO DELAY OR PATIENT HARM WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503633 ↗
• MalfunctionJun 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT ON (B)(6) 2026 MULTIPLE STRANDS OF STRATAFIX SPIRAL NEEDLES SEPARATED AT THE SWAGE DURING TWO DIFFERENT ROBOTIC HYSTERECTOMIES WITH SURGEON. A TOTAL OF 7 SUTURE STRANDS, 3 DURING ONE PROCEDURE, 4 DURING ANOTHER, HAD THE NEEDLES EASILY POP-OFF. THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING ADDITIONAL STRATAFIX SUTURES AND THERE WAS NO ADVERSE PATIENT IMPACT. STAFF DID NOT RETAIN ANY OF THE BROKEN SUTURES OR NEEDLES, NOR DID THEY DOCUMENT THE LOT. NO DELAY OR PATIENT HARM WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503631 ↗
• MalfunctionJun 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT ON (B)(6) 2026 MULTIPLE STRANDS OF BARBED SPIRAL NEEDLES SEPARATED AT THE SWAGE DURING TWO DIFFERENT ROBOTIC HYSTERECTOMIES WITH SURGEON. A TOTAL OF 7 SUTURE STRANDS, 3 DURING ONE PROCEDURE, 4 DURING ANOTHER, HAD THE NEEDLES EASILY POP-OFF. THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING ADDITIONAL BARBED SUTURES AND THERE WAS NO ADVERSE PATIENT IMPACT. STAFF DID NOT RETAIN ANY OF THE BROKEN SUTURES OR NEEDLES, NOR DID THEY DOCUMENT THE LOT. NO DELAY OR PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503045 ↗
• MalfunctionJun 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT ON (B)(6) 2026 MULTIPLE STRANDS OF BARBED SPIRAL NEEDLES SEPARATED AT THE SWAGE DURING TWO DIFFERENT ROBOTIC HYSTERECTOMIES WITH SURGEON. A TOTAL OF 7 SUTURE STRANDS, 3 DURING ONE PROCEDURE, 4 DURING ANOTHER, HAD THE NEEDLES EASILY POP-OFF. THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING ADDITIONAL BARBED SUTURES AND THERE WAS NO ADVERSE PATIENT IMPACT. STAFF DID NOT RETAIN ANY OF THE BROKEN SUTURES OR NEEDLES, NOR DID THEY DOCUMENT THE LOT. NO DELAY OR PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25502613 ↗
• MalfunctionMay 20, 2026Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BROKEN FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228890 ↗
• MalfunctionMay 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. 3 CASES IN TOTAL. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070898 ↗
• MalfunctionMay 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. 3 CASES IN TOTAL. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067976 ↗
• MalfunctionMay 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. 3 CASES IN TOTAL. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067972 ↗
• MalfunctionApr 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. LOT NUMBER IS UNKNOWN. THERE WAS NO EFFECT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018349 ↗
• MalfunctionApr 21, 2026Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE NEEDLE HAD BEEN DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945329 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC BILATERAL INGUINAL AND UMBILICAL HERNIA REPAIR ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING A ROBOTIC BILATERAL INGUINAL AND UMBILICAL HERNIA REPAIR, THE SURGEON TOOK TWO PASSES INTO MEDTRONIC DEXTILE ANATOMICAL MESH WITH THE STRATAFIX SXPP1B432 SUTURE. AS HE WAS TIGHTENING THE SUTURE, IT BROKE AND HE NEEDED TO REMOVE THE SUTURE STRANDS. HE ATTEMPTED TO USE A NEW STRATAFIX TWO MORE TIMES AND THE SAME THING OCCURRED. HE USED A VLOC SUTURE TO COMPLETE THE INGUINAL HERNIA REPAIRS. HE THEN USED AN SXPP1B450 STRATAFIX ON THE UMBILICAL HERNIA REPAIR AND AGAIN THE SUTURE BROKE AFTER A COUPLE OF PASSES. THE SURGEON SWITCHED TO VLOC TO COMPLETE THE SURGERY. HE IS A VERY EXPERIENCED ROBOTIC SURGEON. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICES WERE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940252 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC BILATERAL INGUINAL AND UMBILICAL HERNIA REPAIR ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING A ROBOTIC BILATERAL INGUINAL AND UMBILICAL HERNIA REPAIR, THE SURGEON TOOK TWO PASSES INTO MEDTRONIC DEXTILE ANATOMICAL MESH WITH THE STRATAFIX SXPP1B432 SUTURE. AS HE WAS TIGHTENING THE SUTURE, IT BROKE AND HE NEEDED TO REMOVE THE SUTURE STRANDS. HE ATTEMPTED TO USE A NEW STRATAFIX TWO MORE TIMES AND THE SAME THING OCCURRED. HE USED A VLOC SUTURE TO COMPLETE THE INGUINAL HERNIA REPAIRS. HE THEN USED AN SXPP1B450 STRATAFIX ON THE UMBILICAL HERNIA REPAIR AND AGAIN THE SUTURE BROKE AFTER A COUPLE OF PASSES. THE SURGEON SWITCHED TO VLOC TO COMPLETE THE SURGERY. HE IS A VERY EXPERIENCED ROBOTIC SURGEON. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICES WERE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940242 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC BILATERAL INGUINAL AND UMBILICAL HERNIA REPAIR ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING A ROBOTIC BILATERAL INGUINAL AND UMBILICAL HERNIA REPAIR, THE SURGEON TOOK TWO PASSES INTO MEDTRONIC DEXTILE ANATOMICAL MESH WITH THE STRATAFIX SXPP1B432 SUTURE. AS HE WAS TIGHTENING THE SUTURE, IT BROKE AND HE NEEDED TO REMOVE THE SUTURE STRANDS. HE ATTEMPTED TO USE A NEW STRATAFIX TWO MORE TIMES AND THE SAME THING OCCURRED. HE USED A VLOC SUTURE TO COMPLETE THE INGUINAL HERNIA REPAIRS. HE THEN USED AN SXPP1B450 STRATAFIX ON THE UMBILICAL HERNIA REPAIR AND AGAIN THE SUTURE BROKE AFTER A COUPLE OF PASSES. THE SURGEON SWITCHED TO VLOC TO COMPLETE THE SURGERY. HE IS A VERY EXPERIENCED ROBOTIC SURGEON. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICES WERE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940241 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC BILATERAL INGUINAL AND UMBILICAL HERNIA REPAIR ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING A ROBOTIC BILATERAL INGUINAL AND UMBILICAL HERNIA REPAIR, THE SURGEON TOOK TWO PASSES INTO MEDTRONIC DEXTILE ANATOMICAL MESH WITH THE STRATAFIX SXPP1B432 SUTURE. AS HE WAS TIGHTENING THE SUTURE, IT BROKE AND HE NEEDED TO REMOVE THE SUTURE STRANDS. HE ATTEMPTED TO USE A NEW STRATAFIX TWO MORE TIMES AND THE SAME THING OCCURRED. HE USED A VLOC SUTURE TO COMPLETE THE INGUINAL HERNIA REPAIRS. HE THEN USED AN SXPP1B450 STRATAFIX ON THE UMBILICAL HERNIA REPAIR AND AGAIN THE SUTURE BROKE AFTER A COUPLE OF PASSES. THE SURGEON SWITCHED TO VLOC TO COMPLETE THE SURGERY. HE IS A VERY EXPERIENCED ROBOTIC SURGEON. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICES WERE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940173 ↗
• MalfunctionMar 31, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING TOTAL HYSTERECTOMY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY WHEN THE PRODUCT WAS USED. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745326 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT REPORTED VAGINAL BLEEDING WEEKS OUT REQUIRING EXTRA CLINIC VISITS OR ER VISITS WITH POSSIBLE FULGURATION OF TISSUE. THE MALE PARTNER POTENTIALLY MAY HAVE HAD PENIS PAIN/ CUT DUE TO BARBS DURING INTERCOURSE. THE PATIENT MAY HAVE HAD RESIDUAL SUTURE REQUIRING MULTIPLE VISITS FOR CUTTING THE SUTURE WEEKS AND MONTHS AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24279219 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT REPORTED VAGINAL BLEEDING WEEKS OUT REQUIRING EXTRA CLINIC VISITS OR ER VISITS WITH POSSIBLE FULGURATION OF TISSUE. THE MALE PARTNER POTENTIALLY MAY HAVE HAD PENIS PAIN/ CUT DUE TO BARBS DURING INTERCOURSE. THE PATIENT MAY HAVE HAD RESIDUAL SUTURE REQUIRING MULTIPLE VISITS FOR CUTTING THE SUTURE WEEKS AND MONTHS AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24279198 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT REPORTED VAGINAL BLEEDING WEEKS OUT REQUIRING EXTRA CLINIC VISITS OR EMERGENCY ROOM VISITS WITH POSSIBLE FULGURATION OF TISSUE. THE MALE PARTNER POTENTIALLY MAY HAVE HAD PENIS PAIN/ CUT DUE TO BARBS DURING INTERCOURSE. THE PATIENT MAY HAVE HAD RESIDUAL SUTURE REQUIRING MULTIPLE VISITS FOR CUTTING THE SUTURE WEEKS AND MONTHS AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24279197 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED ON THE VAGINAL CUFF. THE PATIENT EXPERIENCED MODERATE BLEEDING 3 WEEKS POSTOP. MULTIPLE OFFICE VISITS. NO DEHISCENCE BUT TREATED GRANULATION TISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24169019 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED ON THE VAGINAL CUFF. THE PATIENT EXPERIENCED MODERATE BLEEDING AT 4 WEEKS POSTOP, NO DEHISCENCE BUT TINY AMT GRANULATION TISSUE TREATED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24169018 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED ON THE VAGINAL CUFF. THE PATIENT EXPERIENCED ONGOING BLEEDING UP TO 5 WEEKS POST-OPERATION, MULTIPLE OFFICE VISITS. NO DEHISCENCE, NEEDED SILVER NITRATE X 1, WILL NEED EUA IF MORE BLEEDING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24169017 ↗