PDS Z310HRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10705031060418), received between Jan 25, 2018 and Mar 7, 2025 — classified as 1 death, 33 malfunctions.

The most frequently reported specific device problem is “Material Separation” (19 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES WERE BROKEN DURING USE. 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 21547716 ↗
• MalfunctionMar 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES WERE BROKEN DURING USE. 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 21547711 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN GASTROTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT 4-0 PDS ENTEROTOMY CLOSED WITH S.I. 3-0 PDS GASTROTOMY CLOSED WITH SC AND CUSHING PATTERN. PET DEHISCED ON (B)(6) 2024. REVISITATION REQUIRED DUE TO 4-0 PDS TAPER FOR R&A. PET DISCHARGED FROM THE HOSPITAL. LATER RETURNED FOR A (SUSPECTED) DERMATITIS THERMAL BURN THAT LIKELY OCCURRED DURING FIRST SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 20917117 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN GASTROTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT 4-0 PDS ENTEROTOMY CLOSED WITH S.I. 3-0 PDS GASTROTOMY CLOSED WITH SC AND CUSHING PATTERN. PET DEHISCED ON (B)(6) 2024. REVISITATION REQUIRED DUE TO 4-0 PDS TAPER FOR R&A. PET DISCHARGED FROM THE HOSPITAL. LATER RETURNED FOR A (SUSPECTED) DERMATITIS THERMAL BURN THAT LIKELY OCCURRED DURING FIRST SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 20915102 ↗
• MalfunctionAug 21, 2024Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, WHEN PULLED OUT THE SUTURE, THE CATCH WAS HARD AND THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE SOMETIMES CAME OFF. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20012128 ↗
• MalfunctionAug 20, 2024Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, WHEN PULLED OUT THE SUTURE, THE CATCH WAS HARD AND THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE SOMETIMES CAME OFF. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000788 ↗
• MalfunctionMar 19, 2024Material Separation; Material Separation

  IT WAS REPORTED BY A SALES REP THAT, A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935741 ↗
• DeathMar 7, 2024Material Separation; Material Separation

  IT WAS REPORTED BY AN ATTORNEY THAT A PATIENT UNDERWENT A PARTIAL NEPHRECTOMY WITH A ROBOT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE THREAD THAT HAD A NEEDLE AT THE BEGINNING OF THE PROCEDURE WAS REMOVED BY A GRIPPER OF THE ROBOT AND AT THE EXIT OF THE TROCAR BY THE OPERATIVE AID, THE NEEDLE HAD DISAPPEARED (ONLY THE THREAD WAS REMOVED). THE SURGEON WAS IMMEDIATELY NOTIFIED OF THIS INCIDENT. STAFF IMMEDIATELY SEARCHED FOR THE NEEDLE IN THE OPERATIVE CAVITY USING A CAMERA AND THEN AN IMAGE INTENSIFIER, BUT THE NEEDLE WAS NOT FOUND. STAFF BELIEVE THAT THE NEEDLE HAS REMAINED IN THE OPERATING CAVITY. THE POSTOPERATIVE PERIOD WAS UNFORTUNATELY COMPLICATED BY CARDIOPULMONARY ARREST. RESUSCITATION, WITH ADRENALINE INJECTED, WITHOUT EXTERNAL ELECTRIC SHOCK, WAS INITIATED AND PERFORMED FOR 20 MINUTES. CARDIO-RESPIRATORY RHYTHM DID NOT RECOVER, DECISION TO STOP RESUSCITATION IN MULTIDISCIPLINARY CONSULTATION, AND DEATH OF THE PATIENT. PATIENT DECEASED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Foreign Body In Patient

  MAUDE report 18859514 ↗
• MalfunctionFeb 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE COULD NOT BE PASSED THROUGH THE TISSUE SMOOTHLY, SO THE SURGEON HELD THE NEEDLE AND PULLED A LITTLE BIT STRONGLY, THE JOINT PART BETWEEN THE SUTURE AND THE NEEDLE CAME OFF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658184 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKING DURING USE. THIS HAPPENED IN TWO PACKAGES IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18468088 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKING DURING USE. THIS HAPPENED IN TWO PACKAGES IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18468084 ↗
• MalfunctionMar 24, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON NOTICED THAT THE NEEDLE WAS A SPATULA NEEDLE. FOR YEARS THIS PRODUCT CAME WITH A TAPER NEEDLE, BUT THE PRODUCT WAS RECENTLY CHANGED TO HAVE A SPATULA NEEDLE INSTEAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13896293 ↗
• MalfunctionOct 26, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CASTRATION SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED WHEN PERFORMING INSTRUMENT TIE DURING INTERRUPTED SUTURING ON THE FASCIA. THE SURGEON COMPLETED THE WOUND CLOSURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12700463 ↗
• MalfunctionJul 7, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ADHESIOLYSIS PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD PULLED FROM THE NEEDLE AND THE NEEDLE FALLEN INSIDE THE PATIENT. THE NEEDLE HAS BEEN RECOVERED WITHOUT SCOPY BUT RISK OF INJURY FOR THE PATIENT AND THE USER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132003 ↗
• MalfunctionMar 23, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN PARTIAL RESECTION OF THE DUODENUM ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE FULL THICKNESS SUTURING OF THE INTESTINE WAS PERFORMED BY CONTINUOUS SUTURING, THE NEEDLE TIP WAS MISSING AT THE 4 TO 5TH STITCH. BECAUSE IT COULD NOT BE FOUND IN THE JAW OF THE NEEDLE HOLDER, INTRAOPERATIVE X-RAY WAS PERFORMED. THE WOUND WAS CLOSED, AND THE SURGERY WAS COMPLETED BECAUSE THERE SEEMED TO BE NO RESIDUAL. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE NEEDLE HOLDER WAS CHANGED FOR EACH NEEDLE-SUTURE USED, AND THERE SHOULD BE NO MISMATCHING. POSTOPERATIVE CT WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2021. AS A RESULT OF CT EXAMINATION, NO FOREIGN MATTERS SUCH AS NEEDLE TIP WERE FOUND. THE PATIENT'S CONDITION IS NORMAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553548 ↗
• MalfunctionJan 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE THREAD. THE CUSTOMER DOES NOT HAVE THE EXACT INFORMATION ON THE NUMBER OF PATIENTS AFFECTED BY THE INCIDENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11215365 ↗
• MalfunctionJan 14, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2020 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11174445 ↗
• MalfunctionJan 8, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEPHRECTOMY ON (B)(6) 2020 AND SUTURE WAS USED. WHEN TRYING TO USE THE NEEDLE-SUTURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. LOT NUMBER - QCMLTA - UNKNOWN IF THIS IS THE CORRECT LOT NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139578 ↗
• MalfunctionJan 8, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEPHRECTOMY ON (B)(6) 2020 AND SUTURE WAS USED. WHEN TRYING TO USE THE NEEDLE-SUTURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. LOT NUMBER - QCMLTA - UNKNOWN IF THIS IS THE CORRECT LOT NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139574 ↗
• MalfunctionDec 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON UNKNOWN DATE AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. THESE WERE NOT CONTROL RELEASE NEEDLES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019061 ↗
• MalfunctionDec 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON UNKNOWN DATE AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. THESE WERE NOT CONTROL RELEASE NEEDLES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019058 ↗
• MalfunctionDec 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON UNKNOWN DATE AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. THESE WERE NOT CONTROL RELEASE NEEDLES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019057 ↗
• MalfunctionDec 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON UNKNOWN DATE AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. THESE WERE NOT CONTROL RELEASE NEEDLES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019055 ↗
• MalfunctionDec 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON UNKNOWN DATE AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. THESE WERE NOT CONTROL RELEASE NEEDLES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019054 ↗
• MalfunctionDec 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON UNKNOWN DATE AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. THESE WERE NOT CONTROL RELEASE NEEDLES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019053 ↗