MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER SURGICOUNT RFID SPONGES; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Lot Number 1385549

Device Problems Material Frayed (1262); Material Separation (1562); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Our health care system began use of the stryker surgicount system in (b)(6) 2020.From (b)(6) 2020 until present across the health care system issues related to the sponges supplied for use with the surgicount system have had repeated defects reported that could have impact on patient safety.A total of 12 recorded incidents have been reported while in patient use.The following is a breakdown of the defects: 6 are for missing master qr code band, 2 are related to blue loop detachment, and 4 are related to shredding or fraying of the sponge.Stryker has been notified and an independent test of unused products was conducted at our facility per their recommendation with 11 results of the product proving defective during the testing.The defective sponges are present in both the custom sponge packs as well single sponge packs.The sponges are from varied lot number and product id numbers.Fda safety report id# (b)(4).

• Brand Name: STRYKER SURGICOUNT RFID SPONGES
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 10684247
• MDR Text Key: 211719473
• Report Number: MW5097238
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 0612244160
• UDI-Public: 0612-244-160
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/12/2020
• 12 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1385549
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention