ENDO DISSECT
Received Jun 14, 2021 · Event occurred Mar 18, 2021
Report 2647580-2021-02021 · MDR key 11995389
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P6A0128X
Product problems
- Failure to Align
- Failure to Align
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
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 LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE REPORTED STAPLER WAS REMOVED FROM THE PACKAGING, IT WAS FOUND THAT IT HAD NO STAPLE RELOAD LOADED INTO THE JAWS OF THE UNIT AND THE TIP OF JAWS OF THE REPORTED HAND INSTRUMENT WOULD NOT MEET WHEN CLOSED. THE PRODUCTS WERE NOT USED ON PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.