MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SURGICAL TABLET; COUNTER, SPONGE, SURGICAL

Model Number	0794001010
Medical Device Problem Codes	Incorrect Measurement (1383); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, only 4 out of the 9 sponges scanned out on the tablet.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Event or Problem Description
Per the customer, only 4 out of the 9 sponges scanned out on the tablet.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Correction: it was determined this event was not a reportable event per cfr 21, part 803.This supplemental is being filed to identify an mdr was not required for this event.Device not returned.

• Brand Name: SURGICAL TABLET
• Common Device Name: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16725658
• Report Number: 3015967359-2023-00724
• Device Sequence Number: 12759691
• Product Code: GDY
• UDI-Device Identifier: 07613327509090
• UDI-Public: 07613327509090
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K060076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0794001010
• Device Catalogue Number: 0794-001-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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