inforMED
InjuryGET

ENDO DISSECT

Received Feb 23, 2022 · Event occurred Jan 7, 2022

Report 2647580-2022-00599 · MDR key 13587278

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

176645

Catalog number

176645

Product problems

  • Product Quality Problem
  • Difficult to Open or Close
  • Adverse Event Without Identified Device or Use Problem
  • Product Quality Problem
  • Difficult to Open or Close
  • Adverse Event Without Identified Device or Use Problem

Patient

Unknown

  • Unspecified Tissue Injury
  • No Clinical Signs, Symptoms or Conditions
  • Unspecified Tissue Injury
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLAMP WAS APPLIED IN THE DISSECTION OF CALOT'S TRIANGLE, NOTING THAT THE DEVICE IS VERY HARD TO OPEN AND HAS LITTLE OPENING RANGE, WHICH REQUIRES APPLYING A LOT OF FORCE AND MAKING INDELICATE MOVEMENTS, CAUSING AN UNINTENTIONAL TEARING OF THE CYSTIC ARTERY. THE SURGEON SUGGEST CHANGING THE DEVICE FOR OTHER BRANDS FOR THE SAFETY OF THE PATIENT. THE OPERATION WAS EXTENDED FOR MORE THAN THIRTY MINUTES.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLAMP WAS APPLIED IN THE DISSECTION OF CALOT'S TRIANGLE, NOTING THAT THE DEVICE JAWS WAS VERY HARD OR DOES NOT OPEN SMOOTHLY AND HAS LITTLE OPENING RANGE, WHICH REQUIRES APPLYING A LOT OF FORCE AND MAKING INDELICATE MOVEMENTS. THE SURGEON SUGGEST CHANGING THE DEVICE FOR OTHER BRANDS FOR THE SAFETY OF THE PATIENT. THE OPERATION WAS EXTENDED FOR MORE THAN THIRTY MINUTES. THERE WAS NO PATIENT INJURY.