MAUDE Adverse Event Report: STERIS ISRAEL SOLUTIONS LTD. OR LOCATE SPONGE SOLUTION

Model Number	ORLOCATE SPONGE SOLUTION
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.

• Brand Name: OR LOCATE SPONGE SOLUTION
• Common Device Name: SPONGE SOLUTION
• Manufacturer (Section D): STERIS ISRAEL SOLUTIONS LTD.; 2 habanai st.; hod hasharon, hamerkaz 45319 02; IS 4531902
• Manufacturer (Section G): STERIS ISRAEL SOLUTIONS LTD.; 2 habanai st.; hod hasharon, hamerkaz 45319 02; IS 4531902
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16834167
• Report Number: 3008920949-2023-00001
• Device Sequence Number: 3276831
• Product Code: LWH
• UDI-Device Identifier: 00724995220624
• UDI-Public: 00724995220624
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ORLOCATE SPONGE SOLUTION
• Device Catalogue Number: OX100
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2023
• Supplement Date Received by Manufacturer: 04/30/2023; 03/31/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/16/2023; 05/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown