AESCULAP PM973RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04038653183715), received between Mar 2, 2021 and Sep 16, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Break; Break

  ACCORDING TO THE EVENT DESCRIPTION DURING A LAP CHOLE RESECTION A SCISSOR PIN FELL OUT DURING SURGERY INTO THE PATIENT AND WAS NOT LOCATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23061742 ↗
• InjuryDec 1, 2021Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT AN INSULATED OUTER TUBE 5/5MM 310MM (PART # PM973R) WAS USED DURING A LAPAROSCOPIC PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GRASPER SPLINTERED INSIDE PATIENT. REPORTEDLY, THE SURGEON MANAGED TO RETRIEVE SOME, BUT NOT ALL, FRAGMENTS. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A FRAGMENT REMAINED INSIDE THE PATIENT. AN ADDITION MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: PO959R - MONOPOLAR HANDLE WITH RATCHET - BATCH UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12910678 ↗
• InjuryApr 13, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PM973R - INSULATED OUTER TUBE 5/5MM 310MM AS PER INFORMATION RECEIVED VIA MEDWATCH (B)(4). ACCORDING TO THE COMPLAINT DESCRIPTION, THE INSULATION OF THE DEVICE WAS DAMAGED DURING SURGERY. THE PROCEDURE WAS A ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY (BSO). THE SURGEON BEGAN USING A MONOPOLAR SCISSOR WITH CAUTERY TO CUT AN ADHESION. BLACKENED AREA WAS NOTED ABOVE THE ADHESION; IT WAS REMOVED FROM THE STERILE FIELD. A LIGASURE WAS THEN OPENED TO CONTINUE THE DISSECTION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE DEVICE APPEARED TO HAVE CRACKED INSULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656825 ↗
• InjuryApr 7, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PM973R - INSULATED OUTER TUBE 5/5MM 310MM AS PER INFORMATION RECEIVED VIA MEDWATCH (B)(4). ACCORDING TO THE COMPLAINT DESCRIPTION, THE INSULATION OF THE DEVICE WAS DAMAGED DURING SURGERY. THE PROCEDURE WAS A ROBOT-ASSISTED LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY (BSO). THE SURGEON BEGAN USING A MONOPOLAR SCISSOR WITH CAUTERY TO CUT AN ADHESION. BLACKENED AREA WAS NOTED ABOVE THE ADHESION; IT WAS REMOVED FROM THE STERILE FIELD. A LIGASURE WAS THEN OPENED TO CONTINUE THE DISSECTION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE DEVICE APPEARED TO HAVE CRACKED INSULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629027 ↗
• InjuryMar 3, 2021Break; Break

  AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THIS EVENT PROLONGED THE SURGERY FOR 10-15 MINUTES. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE XC 100027414; CC 400502022. INVOLVED COMPONENTS: PM777R - JAW INS.TENACULUM FORCEPS D:5/310MM - LOT UNKNOWN PO959R - MONOPOLAR HANDLE WITH RATCHET - LOT UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11406223 ↗
• InjuryMar 2, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CORRECTION: ARTICLE NUMBER CHANGED FROM PO224R TO PM973R - INSULATED OUTER TUBE 5/5MM 310MM. THIS ITEM CHANGED FROM LEADING MATERIAL TO INVOLVED COMPONENT. THEREFORE, THIS CASE IS NO LONGER REPORTABLE. ALL FURTHER INFORMATION IS INCLUDED AND UPDATED IN THE LEADING MATERIAL REPORT (9610612-2021-00266). ASSOCIATED MEDWATCH: 9610612-2021-00266 (400506296 - PO777R). INVOLVED COMPONENTS: PM973R - INSULATED OUTER TUBE 5/5MM 310MM - LOT UNKNOWN. PO959R - MONOPOLAR HANDLE WITH RATCHET - LOT UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399868 ↗