OR LOCATE SPONGE SOLUTION
Received Apr 28, 2023 · Event occurred Sep 3, 2020
Report 3008920949-2023-00001 · MDR key 16834167
Device
Generic name
Sponge Solution
Manufacturer
Steris Israel Solutions Ltd.Model number
ORLOCATE SPONGE SOLUTIONCatalog number
OX100
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE OPERATION ROOM LOCATE SYSTEM USES RFID TECHNOLOGY TO TRACK SPONGES (BEFORE, DURING, AND AFTER) SURGICAL PROCEDURES TO AVOID UN-INTENTIONALLY RETAINED SURGICAL ITEMS. AT THIS POINT, THERE HAS BEEN NO ALLEGATION THAT THE OR LOCATE SYSTEM CAUSED OR CONTRIBUTED TO THIS REPORTED EVENT; HOWEVER, OUT OF AN ABUNDANCE OF CAUTION, STERIS HAS ELECTED TO REPORT THIS EVENT BASED ON A LACK OF AVAILABLE INFORMATION AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
Description of Event or Problem
STERIS WAS CONTACTED BY AN ATTORNEY REPRESENTING THE USER FACILITY ON 3/31/2023 REGARDING LITIGATION ALLEGING A SPONGE WAS LEFT IN A PATIENT'S PELVIC CAVITY DURING A PROCEDURE THAT OCCURRED ON (B)(6) 2020. IT WAS REPORTED THAT THE PROCEDURE SUBJECT OF THE EVENT INCLUDED USE OF THE OR LOCATE SPONGE SOLUTION.