InjuryOCZ
BIB REMOVAL TOOL WIRE GRASPER
Received May 7, 2021 · Event occurred Apr 7, 2021
Report 3006722112-2021-00031 · MDR key 11793233
Device
Generic name
Wire Grasper
Manufacturer
Apollo Endosurgery, Inc.Model number
B-40814Catalog number
B-40814
Lot number
2833109
Product problems
- Mechanical Problem
- Device Damaged by Another Device
- Mechanical Problem
- Device Damaged by Another Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INITIAL MEDWATCH SUBMITTED TO THE FDA ON (B)(6) 2021. THE DEVICE WAS RETURNED TO THE APOLLO DEVICE ANALYSIS LABORATORY ON 03/MAY/2021. ANALYSIS OF THE DEVICE IS ONGOING.
Description of Event or Problem
PHYSICIAN EXPERIENCED DIFFICULTIES IN REMOVING THE BALLOON AS THE GRASPER MALFUNCTIONED.