AESCULAP PO958RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653464081), received between Jun 27, 2025 and Jun 27, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED TO AESCULAP INC. THAT A MONOPOLAR HANDLE WITHOUT RATCHET (PART # PO958R) WAS USED DURING A COLECTOMY, SIGMOID, LAPAROSCOPIC PROCEDURE ON (B)(6) 2025. ACCORDING TO THE COMPLAINT DESCRIPTION, MULTIPLE INSERTS WERE STIFF AND DIFFICULT TO OPEN/MANIPULATE. THE TYPE OF PROCEDURE WAS A LAPAROSCOPIC SIGMOID COLECTOMY. THERE WAS A 20-MINUTE DELAY WHILE CONVERTING TO AN OPEN LAPAROTOMY PROCEDURE. 2916714-2025-00043, AIC REFERENCE (B)(4), 2916714-2025-00044, AIC REFERENCE (B)(4), 2916714-2025-00045, AIC REFERENCE (B)(4), 2916714-2025-00046, AIC REFERENCE (B)(4), 2916714-2025-00047, AIC REFERENCE (B)(4), 2916714-2025-00048, AIC REFERENCE (B)(4), 2916714-2025-00049, AIC REFERENCE (B)(4), AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344815 ↗
• InjuryJun 27, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED TO AESCULAP INC. THAT A MONOPOLAR HANDLE WITHOUT RATCHET (PART # PO958R) WAS USED DURING A COLECTOMY, SIGMOID, LAPAROSCOPIC PROCEDURE ON (B)(6) 2025. ACCORDING TO THE COMPLAINT DESCRIPTION, MULTIPLE INSERTS WERE STIFF AND DIFFICULT TO OPEN/MANIPULATE. THE TYPE OF PROCEDURE WAS A LAPAROSCOPIC SIGMOID COLECTOMY. THERE WAS A 20-MINUTE DELAY WHILE CONVERTING TO AN OPEN LAPAROTOMY PROCEDURE. 2916714-2025-00043 AIC REFERENCE (B)(4), 2916714-2025-00044 AIC REFERENCE (B)(4), 2916714-2025-00045 AIC REFERENCE (B)(4), 2916714-2025-00046 AIC REFERENCE (B)(4), 2916714-2025-00047 AIC REFERENCE (B)(4), 2916714-2025-00048 AIC REFERENCE (B)(4), AIC REFERENCE (B)(4), 2916714-2025-00050 AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344810 ↗