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

Model Number	0794001010
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, a different sponge was scanned in with the pack.The procedure was completed successfully without a delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
It was determined after receiving further clarification that this event was not a reportable event per cfr 21, part 803.The reported event of scanning another sponge into a case has not lead to a serious injury or adverse event in the past.This supplemental is being filed to identify a mdr was not required for this event.
Event or Problem Description
Per urt case the rfid sponge ew0g-ggnc-5db3 got scanned in with a different pack.The procedure was completed successfully without a delay; no medical intervention or adverse consequences were reported.

• 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: 16722934
• Report Number: 3015967359-2023-00718
• Device Sequence Number: 18130032
• Product Code: GDY
• UDI-Device Identifier: 07613327509090
• UDI-Public: 07613327509090
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K060076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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