MAUDE Adverse Event Report: STRYKER INSTRUMENTS SURGICOUNT; COUNTER, SPONGE, SURGICAL

Model Number SURGICOUNT LAP SPONGE 5 CT.

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

Surgicount sponges would not properly scan in with faulty qr code.

• Brand Name: SURGICOUNT
• Type of Device: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 18486410
• MDR Text Key: 332801629
• Report Number: MW5150082
• Device Sequence Number: 1
• Product Code: LWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SURGICOUNT LAP SPONGE 5 CT.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1