inforMED
InjuryGET

ENDO DISSECT

Received Feb 24, 2022

Report 2647580-2022-00606 · MDR key 13589376

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

176645

Catalog number

176645

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Unknown

  • Unspecified Tissue Injury
  • Unspecified Tissue Injury

Narrative

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT EXPERIENCED AN UNINTENTIONAL TEARING OF THE CYSTIC ARTERY. THE DEVICE HAD A RIGID OPENING AND INCREASE THE RISK FOR THE DISSECTION OF DELICATE TISSUES. THEY ARE NOT SUITABLE HAND INSTRUMENT FOR DISSECTION IN VESICLES AND IT IS A STRUCTURAL PROBLEM OF THE BRAND SINCE THEY ARE NEW FORCEPS.