AESCULAP PL595SURecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046963915025), received between Mar 18, 2021 and Dec 29, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2023Break; Break

  IT WAS REPORTED TO AESCULAP INC. THAT A SILICONE RING WITH NEEDLE (PART# PL595SU) WAS USED DURING A PROCEDURE ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, WHILE RETRACTING THE GALLBLADDER, THE GRAY SILICONE RING SNAPPED IN HALF AND DETACHED ON THE PATIENT'S GALLBLADDER WITH THE CLIP ATTACHED. THE RING WAS RETRIEVED WITH A GRASPER AND NO IMAGING WAS REQUIRED. THE SILICONE RING WAS DISCARDED, AND THEREFORE, WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416831 ↗
• MalfunctionOct 29, 2021Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED TO AESCULAP AG THA A SILICONE RING WITH NEEDLE (PART # PL595SU) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, IT WAS REPORTED THAT THE SILICONE RING WAS TORN. REPORTEDLY, THE CUSTOMER HELD THE NEEDLE AND SET IT, BUT THE SILICONE RING TORE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00683 (400530801 PL595SU). 9610612-2021-00684 (400530802 PL595SU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719762 ↗
• MalfunctionOct 29, 2021Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED TO AESCULAP AG THA A SILICONE RING WITH NEEDLE (PART # PL595SU) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, IT WAS REPORTED THAT THE SILICONE RING WAS TORN. REPORTEDLY, THE CUSTOMER HELD THE NEEDLE AND SET IT, BUT THE SILICONE RING TORE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00684 (400530802 PL595SU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719755 ↗
• MalfunctionSep 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL595SU - SILICONE RING WITH NEEDLE. ACCORDING TO THE COMPLAINT DESCRIPTION, THIS PRODUCT WAS USED DURING THE LIVER ELEVATION IN ABDOMINAL SURGERY FOR VAST ESOPHAGEAL SURGERY. THE SILICONE RING WAS TORN. THE DOCTOR SAID HE DIDN'T TOUCH THE SILICON WITH FORCEPS. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12454139 ↗
• MalfunctionMar 18, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A SILICONE RING WITH NEEDLE (PART # PL595SU) WAS USED DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SILICONE RINGS OF THE DEVICE WERE TORN. REPORTEDLY, WHILE REMOVING THE HOOK NEEDLE FROM THE ABDOMINAL WALL BEFORE THE END OF SURGERY, THE SILICONE RUBBER BROKE AND THE HOOK NEEDLE FELL INTO THE ABDOMINAL CAVITY. THE FRAGMENT WAS RECOVERED FROM THE PATIENT'S BODY USING X-RAY. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISCARDED. THE SURGERY TIME POSSIBLY EXTENDED DUE TO INTRA OPERATIVE X-RAY EXAMINATION TO SEARCH FOR THE NEEDLE IN THE OPERATIVE FIELD. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516224 ↗