MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SURGICOUNT+ SAFE-T-LAP SPONGE, 18X18, RFID, ENHANCED XRAY; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Catalog Number	0621-018-180
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, the device could not count sponges.Per the customer, a sponge was left in the patient, it is unclear if it was removed.Additional information has been requested from the user facility.
Additional Manufacturer Narrative
Update b1/h1 additional manufacturing narrative: per further clarification from the account, there was no sponge left in the patient.Update: h3, h6 correction: follow-up report submitted to document the device was not available for evaluation.H3 other text : device not returned.
Event or Problem Description
Per the customer, the device could not count sponges.Per clarification from the director of perioperative services at the account, there was no sponge left in a patient.The sponges were manually counted as they were not able to be scanned at the end of the case.All sponges were accounted for when the procedure concluded.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• Brand Name: SURGICOUNT+ SAFE-T-LAP SPONGE, 18X18, RFID, ENHANCED XRAY
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• 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: 18158701
• Report Number: 3015967359-2023-02484
• Device Sequence Number: 8045183
• Product Code: GDY
• UDI-Device Identifier: 57613327512712
• UDI-Public: 57613327512712
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 0621-018-180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown