PGAC300 MINIGRIP ALLIGATOR GRASPER
Received Apr 24, 2018
Report 3002770040-2018-12346 · MDR key 7454162
Device
Generic name
Alligator Grasper
Manufacturer
Grace Manufacturing Inc.Model number
PGAC300 MINIGRIP ALLIGATOR GRASPERCatalog number
PGAC300
Lot number
GML-00156
Product problems
- Use of Device Problem
- Improper or Incorrect Procedure or Method
- Use of Device Problem
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Known Impact Or Consequence To Patient
- Missing Value Reason
- No Known Impact Or Consequence To Patient
- Missing Value Reason
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE SUPRARENAL LAPAROSCOPIC SURGERY SUPRARENAL PERFORMED BY DR. (B)(6), THE OPENING WAS PERFECT, WITHOUT ANY ISSUE. THE INCIDENT HAPPENED WHEN THE RETRACTION OF THE ADIPOSE BROKE. ADDITIONAL INFO. DEVICE USED PER IFU: YES. HARM OR INJURY TO THE PATIENT? NO. DID ANY BROKEN PART REMAIN INSIDE THE PATIENT? NO. IF SO HOW WERE THEY REMOVED? THE PIECE WAS REMOVED USING ANOTHER GRASPER WITHOUT ANY DIFFICULTLY.
Additional Manufacturer Narrative
THE INITIAL SUBMISSION WAS ERRONEOUSLY SUBMITTED AS A 5 DAY REPORT AND THE FIRM WAS NOT REQUIRED TO INITIATE ACTION TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE SUPRARENAL LAPAROSCOPIC SURGERY SUPRARENAL PERFORMED BY DR (B)(6), THE OPENING WAS PERFECT, WITHOUT ANY ISSUE. THE INCIDENT HAPPENED WHEN THE RETRACTION OF THE ADIPOSE BROKE. ADDITIONAL INFO: DEVICE USED PER IFU: YES. HARM OR INJURY TO THE PATIENT? NO. DID ANY BROKEN PART REMAIN INSIDE THE PATIENT? NO. IF SO HOW WERE THEY REMOVED? THE PIECE WAS REMOVED USING ANOTHER GRASPER WITHOUT ANY DIFFICULTLY.