MalfunctionOHD

LSRHKGYN

Received Sep 18, 2018 · Event occurred Aug 22, 2018

Report 7884758 · MDR key 7884758

Device

Generic name

Gynecological Laparoscopic Kit

Manufacturer

Leesar, Inc.

Lot number

921181, 876181, 900181, 834181

Product problems

Product Quality Problem
Manufacturing, Packaging or Shipping Problem

Patient

Not reported

No Information
No Information

Narrative

Description of Event or Problem

OPERATING ROOM STAFF FOUND ISSUES WITH MULTIPLE LEESAR CUSTOM PACKS. PN LSRHHMINORD- 1PK OF 4X4 X-RAY 16-PLY LEFT OUT (LOT# 921181); PN LSRHHGYNLAC- 4X4 X-RAY, 16-PLY HAD 12 INSTEAD OF 10 (LOT# 876181); PN LSRHHGYNLAC- 4X4 X-RAY, 16-PLY HAD 8 INSTEAD OF 10 (LOT# 876181); PN LSRHHTOHIPB- HAS HAIR IN THE PACK, PACK IS UNOPENED (LOT# 900181). LN 3861000 INCORRECT RAYTEX COUNT; THE PACK HAD A TOTAL OF TWO PACKS INSTEAD OF ONE (LOT#834181).