MAUDE Adverse Event Report: STRYKER CORPORATION STRYKER SURGI COUNT TABLET; COUNTER, SPONGE, SURGICAL

Model Number 0694-001-010

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

Event Date 08/14/2023

Event Type  malfunction  

Event Description

Sponge counter malfunction, would not come on, screen black.Sponges could not be counted out on the sponge counter.But all sponges were accounted for.

• Brand Name: STRYKER SURGI COUNT TABLET
• Type of Device: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 17728894
• MDR Text Key: 323174675
• Report Number: 17728894
• Device Sequence Number: 1
• Product Code: LWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0694-001-010
• Device Catalogue Number: 0694-001-010
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Male