MalfunctionGDY
ROBOTIC/LAPAROSCOPY KITTNER ROLLS MEDIUM 4" LONG 5PK 25PKS/CS
Received Jul 14, 2025 · Event occurred May 16, 2022
Report 2951379-2022-00001 · MDR key 22503008
Device
Generic name
Sterile Kittner Roll
Manufacturer
Carefree Surgical Specialties, Inc.Model number
15505/25Lot number
1436
Product problems
- Manufacturing, Packaging or Shipping Problem
- Manufacturing, Packaging or Shipping Problem
Patient
25 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
COUNTED 5 KITTNER ROLLS AT BEGINNING OF CASE. AT THE END OF CASE THERE WERE 6 KITTNERS. THEY MAY HAVE STUCK TOGETHER.
Additional Manufacturer Narrative
CUSTOMER REPORTED INCORRECT QUANTITY IN SKU 15505/25 LOT 1436. PACKAGE LABELED AS 5-PACK CONTAINED 6 UNITS. NO ADVERSE REACTIONS REPORTED. ROOT CAUSE DETERMINED TO BE OPERATOR OVERSIGHT DURING FINAL PACKAGING. STAFF WAS RETRAINED AND ADDITIONAL PACKAGING CHECKS IMPLEMENTED. DEVICE WAS NOT RETURNED FOR EVALUATION.
Remedial action
- Replace