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

Model Number ORLOCATE SPONGE SOLUTION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/03/2020

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 314205433
• Report Number: 3008920949-2023-00001
• Device Sequence Number: 1
• Product Code: LWH
• UDI-Device Identifier: 00724995220624
• UDI-Public: 00724995220624
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ORLOCATE SPONGE SOLUTION
• Device Catalogue Number: OX100
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1