Coated VICRYL VCP771DRecalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10705031055452), received between Nov 19, 2019 and Aug 4, 2026 — classified as 3 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Break” (37 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); they may or may not involve this specific model.

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 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50129601 ↗
• MalfunctionJun 16, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE NURSE PREPARED PREOPERATIVE ITEMS AND FOUND A YELLOW FOREIGN OBJECT INSIDE THE NEWLY OPENED SUTURE. IT WAS DISCARDED AND REPLACED WITH A NEW SUTURE, AND THE ABOVE SITUATION DID NOT OCCUR AGAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521785 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  TITLE: LONG-TERM OUTCOMES OF MODIFIED ENHANCED RECOVERY AFTER SURGERY (MERAS) PROTOCOLS IN PERI-OPERATIVE MANAGEMENT OF MINIMALLY INVASIVE ESOPHAGECTOMY. THE AIM OF THIS STUDY IS TO COMPARE POST-OPERATIVE MORBIDITY, FUNCTIONAL RECOVERY, AND HOSPITAL STAY IN PATIENTS UNDERGOING ESOPHAGECTOMY WITH MODIFIED ERAS (MERAS) PROTOCOLS VERSUS CONVENTIONAL STANDARD CARE (SC), AND TO ASSESS THE EFFECT OF ERAS ON LONG-TERM SURVIVAL OUTCOMES. BETWEEN JUNE 1, 2017 AND MARCH 30, 2019, A TOTAL OF 230 CONSECUTIVE PATIENTS WITH ESOPHAGEAL CARCINOMA WHO UNDERWENT ESOPHAGECTOMY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: THE MERAS GROUP, MANAGED ACCORDING TO MODIFIED ERAS (MERAS) PROTOCOLS WERE USING VCP771D (VICRYL PLUS, ETHICON), AND THE STANDARD CARE (SC) GROUP WERE USING SILK SUTURES (4-0, SILK). REPORTED COMPLICATIONS ARE: VCP771D N=2 ANASTOMOTIC LEAKAGE, TREATMENT: NOT REPORTED. N=11 VOCAL CORD PARESIS, TREATMENT: NOT REPORTED. N=18 PULMONARY INFECTION, TREATMENT: NOT REPORTED. N=1 CHYLOUS LEAKAGE, TREATMENT: NOT REPORTED. N=2 READMISSION, TREATMENT: N/A. IN CONCLUSION, THE IMPLEMENTATION OF MERAS PROTOCOLS CAN SIGNIFICANTLY OPTIMIZE POSTOPERATIVE RECOVERY, REDUCE COMPLICATIONS, AND IMPROVE SURV

  Patient problems: Failure to Anastomose; Insufficient Information; Speech Disorder; Unspecified Infection

  MAUDE report 25127461 ↗
• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SMALL INTESTINE RESECTION SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 17:30, THE INTEGRITY AND EXPIRATION DATE OF THE SUTURE OUTER PACKAGING WERE CHECKED BEFORE SURGERY, AND IT WAS USED AFTER CONFIRMATION. DURING THE SURGERY, THE DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE PROCESS OF SUTURING THE SURFACE OF THE SKIN, AND IMMEDIATELY STOPPED THE OPERATION, REPLACED THE SUTURE WITH A NEW ONE TO CONTINUE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872551 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE TIP HAD BROKEN AS ATTACHED DURING SEWING. THE BROKEN TIP WAS REMOVED FROM PATIENT DURING SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816746 ↗
• MalfunctionApr 7, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT IT WAS FOUND THAT THERE HAD BEEN FOREIGN MATTER IN THE NEWLY DISPENSED SUTURE BEFORE THE SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY. THERE IS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801409 ↗
• MalfunctionDec 17, 2025Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST CYSTECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SURGEON USED THE SUTURE FOR SUTURING THE BREAST STUMP IN THE WAY OF INTERRUPTED SUTURING DURING THE SURGERY. DURING THE SUTURING, THE NEEDLE COULD NOT PENETRATE THE TISSUE. IT WAS FOUND THAT THE NEEDLE TIP WAS MISSING (THE SPECIFIC MISSING LENGTH WAS UNKNOWN). THE SURGEON IMMEDIATELY SEARCHED FOR THE MISSING NEEDLE TIP BUT FAILED. THE SURGERY WAS COMPLETED ROUTINELY. AFTER THE SURGERY, THE PATIENT WAS GIVEN FILM EXAMINATION, AND THE MISSING NEEDLE TIP WAS STILL NOT FOUND IN THE PATIENT'S BODY. THE EVENT RESULTED IN A SURGERY TIME EXTENSION OF ABOUT 15 MINUTES. THE HOSPITAL FEEDBACK COULD NOT CONFIRM WHETHER THE NEEDLE TIP BROKE DURING THE INTRAOPERATIVE SUTURING OR THE NEEDLE TIP ITSELF WAS MISSING. THE PATIENT WAS CURRENTLY IN A STABLE CONDITION. NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827689 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729693 ↗
• MalfunctionOct 20, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THERE WAS ONE PACKAGE OF PRODUCT LESS THAN EXPECTED IN THE BOX WHEN JUST OPENED . THERE SHOULD BE TWELVE PACKAGE OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY ELEVEN PACKAGE OF PRODUCTS . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341369 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCTECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS HOSPITALIZED DUE TO RECTAL CANCER. AT 10:00 ON THE SAME DAY, THE DOCTOR FOUND THAT THE SUTURE WAS NOT FIRM AND COULD BE EASILY BROKEN WITH ONE HAND BEFORE SUTURING. IT WAS IMMEDIATELY REPORTED TO THE HEAD NURSE, AND THE SUTURE WAS REPLACED FOR USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299371 ↗
• MalfunctionSep 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY FOR COMMON BILE DUCT STONES WITH CHOLANGITIS ON (B)(6) 2025 AND SUTURE WAS USED ON THE TISSUE. DURING THE SURGERY, THE LEAD SURGEON HELD A NEEDLE AND THREAD AND INSERTED IT INTO THE PATIENT'S ABDOMEN THROUGH A LAPAROSCOPIC PUNCTURE SHEATH. UNDER DIRECT VISUALIZATION, THE NEEDLE DISAPPEARED, BUT THE SUTURE WAS STILL PRESENT. IT WAS DETERMINED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE ANESTHESIOLOGIST WAS IMMEDIATELY INFORMED TO STRENGTHEN PATIENT MONITORING. AT THE SAME TIME, THE LEAD SURGEON, ASSISTANT PHYSICIAN, AND NURSE CAREFULLY SEARCHED THE PATIENT'S ABDOMINAL CAVITY AND INTERNAL AND EXTERNAL ENVIRONMENT. FINALLY, THE NEEDLE WAS FOUND AT THE OMENTUM IN THE PATIENT'S LOWER ABDOMEN, REMOVED. SUTURE WAS REPLACED WITH A NEW NEEDLE AND SUTURE TO CONTINUE THE SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED. DUE TO THE PATIENT BEING AN ELDERLY AND CRITICALLY ILL PATIENT WITH A SEVERE PREOPERATIVE CONDITION, THIS INCIDENT PROLONGED THE PATIENT'S SURGERY AND ANESTHESIA TIME, INCREASING THE RISKS OF SURGERY AND ANESTHESIA. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038932 ↗
• MalfunctionSep 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY FOR COMMON BILE DUCT STONES WITH CHOLANGITIS ON (B)(6) 2025 AND SUTURE WAS USED ON THE TISSUE. DURING THE SURGERY, THE LEAD SURGEON HELD A NEEDLE AND THREAD AND INSERTED IT INTO THE PATIENT'S ABDOMEN THROUGH A LAPAROSCOPIC PUNCTURE SHEATH. UNDER DIRECT VISUALIZATION, THE NEEDLE DISAPPEARED, BUT THE SUTURE WAS STILL PRESENT. IT WAS DETERMINED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE ANESTHESIOLOGIST WAS IMMEDIATELY INFORMED TO STRENGTHEN PATIENT MONITORING. AT THE SAME TIME, THE LEAD SURGEON, ASSISTANT PHYSICIAN, AND NURSE CAREFULLY SEARCHED THE PATIENT'S ABDOMINAL CAVITY AND INTERNAL AND EXTERNAL ENVIRONMENT. FINALLY, THE NEEDLE WAS FOUND AT THE OMENTUM IN THE PATIENT'S LOWER ABDOMEN, REMOVED. SUTURE WAS REPLACED WITH A NEW NEEDLE AND SUTURE TO CONTINUE THE SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED. DUE TO THE PATIENT BEING AN ELDERLY AND CRITICALLY ILL PATIENT WITH A SEVERE PREOPERATIVE CONDITION, THIS INCIDENT PROLONGED THE PATIENT'S SURGERY AND ANESTHESIA TIME, INCREASING THE RISKS OF SURGERY AND ANESTHESIA. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038763 ↗
• MalfunctionAug 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY FOR COMMON BILE DUCT STONES WITH CHOLANGITIS ON (B)(6) 2015, AND SUTURE WAS USED ON THE TISSUE. DURING THE SURGERY, THE LEAD SURGEON HELD A NEEDLE AND THREAD AND INSERTED IT INTO THE PATIENT'S ABDOMEN THROUGH A LAPAROSCOPIC PUNCTURE SHEATH. UNDER DIRECT VISUALIZATION, THE NEEDLE DISAPPEARED, BUT THE SUTURE WAS STILL PRESENT. IT WAS DETERMINED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE ANESTHESIOLOGIST WAS IMMEDIATELY INFORMED TO STRENGTHEN PATIENT MONITORING. AT THE SAME TIME, THE LEAD SURGEON, ASSISTANT PHYSICIAN, AND NURSE CAREFULLY SEARCHED THE PATIENT'S ABDOMINAL CAVITY AND INTERNAL AND EXTERNAL ENVIRONMENT. FINALLY, THE NEEDLE WAS FOUND AT THE OMENTUM IN THE PATIENT'S LOWER ABDOMEN, REMOVED. SUTURE WAS REPLACED WITH A NEW NEEDLE AND SUTURE TO CONTINUE THE SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED. DUE TO THE PATIENT BEING AN ELDERLY AND CRITICALLY ILL PATIENT WITH A SEVERE PREOPERATIVE CONDITION, THIS INCIDENT PROLONGED THE PATIENT'S SURGERY AND ANESTHESIA TIME, INCREASING THE RISKS OF SURGERY AND ANESTHESIA. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810089 ↗
• MalfunctionJul 31, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED PRIOR TO USE. TOTAL 4 PRODUCTS OCCURRED DAMAGED - PRIMARY PACKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677641 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, MEDICAL STAFF IN THE ANESTHESIA DEPARTMENT DISCOVERED THAT ONE OF THE EIGHT NEEDLES HAD NO NEEDLE TIP, BUT ITS LENGTH WAS NO DIFFERENT FROM THE OTHERS. MEDICAL STAFF IMMEDIATELY STOPPED USING IT AND REPLACED IT WITH A NEW ONE FOR THE PATIENT. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920880 ↗
• MalfunctionApr 23, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 03/03/2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, INCORRECT QUANTITY-MISSING PACKAGES . IT WAS REPORTED THAT THERE WAS ONE PACKAGE OF PRODUCT LESS THAN EXPECTED WHEN PREPARING FOR TRAUMA SURGERY . THERE SHOULD BE TWELVE PACKAGE OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY ELEVEN PACKAGE OF PRODUCTS . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. T UPON VISUAL INSPECTION OF THE RECEIVED BOX, IT WAS NOTED THAT IT CONTAINED ELEVEN FOIL PACKETS INSTEAD OF THE REQUIRED TWELVE. ADDITIONALLY, THE FOIL PACKETS WERE FOUND TO BE RELABELED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894666 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, THERE WAS MISSING THE TIP OF ONE OF EIGHT CONTROL RELEASE NEEDLES. IT WAS A CONTROL RELEASE NEEDLE. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698115 ↗
• InjuryFeb 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE REINFORCEMENT OF THE ANASTOMOTIC SITE AFTER LATERAL ANASTOMOSIS, IT WAS FOUND THAT THE CURRENT TIP WAS MISSING DURING NEEDLE INSERTION. IMMEDIATE SEARCH WAS CONDUCTED, BUT TO NO AVAIL. THE CHIEF SURGEON THEN DECIDED TO REMOVE THE ANASTOMOTIC SITE AND PERFORM A LATERAL ANASTOMOSIS AGAIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21445835 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS USED FOR SURGICAL SUTURING. DURING THE SUTURING PROCESS, THE NEEDLE BROKE, AND THE PHYSICIAN PROMPTLY REMOVED IT FROM THE PATIENT'S BODY AND TOOK X-RAYS TO CONFIRM THAT THERE WAS NO RESIDUE IN THE PATIENT'S BODY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266399 ↗
• MalfunctionJan 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DUE TO SURGICAL REQUIREMENTS, SUTURE WAS USED AND OPERATED ACCORDING TO THE INSTRUCTIONS. WHEN OPENING THE PACKAGING CLIP TO RETRIEVE THE NEEDLE, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. IMMEDIATELY REPLACE THE INSTRUMENT WITH A NEW ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126763 ↗
• MalfunctionNov 6, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622711 ↗
• MalfunctionOct 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY. DURING THE SUTURING PROCESS, THE SURGEON FOUND THAT THE CONNECTION BETWEEN THE NEEDLE AND THE SUTURE WAS EASY TO FALL OFF. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461972 ↗
• MalfunctionAug 23, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN COMMON BILE DUCT INCISION FOR STONE REMOVAL, CHOLANGIOSCOPY EXPLORATION FOR STONE REMOVAL, T-TUBE DRAINAGE, ABDOMINAL DRAINAGE SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE OPERATION OF SUTURING THE COMMON BILE DUCT (APPROXIMATELY 20:10 MINUTES), THE DOCTOR FOUND THAT ONE OF THE NEEDLES WAS BENT AND DIFFICULT TO INSERT, SO THE NEEDLE WAS REMOVED. AFTER REMOVING THE NEEDLE, IT WAS DISCOVERED THAT THE TIP OF THE NEEDLE WAS MISSING. THE DOCTOR REPEATEDLY SEARCHED THE ABDOMINAL CAVITY AND WOUND WITHOUT FINDING A NEEDLE TIP, AND USED A "C-ARM X-RAY MACHINE" TO SHOOT THE NEEDLE TIP THAT WAS NOT MISSING IN THE ABDOMINAL CAVITY. BASED ON THE CURRENT STATUS OF THE HOSPITAL'S INSTRUMENTS AND EQUIPMENT, THE HOSPITAL'S HAVE NOT BEEN ABLE TO IDENTIFY THE LOCATION OF THE NEEDLE TIP DEFECT, BUT THE HOSPITAL'S CANNOT RULE OUT THE POSSIBILITY OF RESIDUAL FOREIGN BODIES IN THE ABDOMINAL CAVITY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20048459 ↗
• MalfunctionJun 21, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. A HUMAN HAIR WAS FOUND IN THE PRODUCT BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582097 ↗
• MalfunctionMay 1, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON APRIL 22, 2024, AND SUTURE WAS USED. IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED PRIOR TO USE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222814 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and