MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp SurgiCount+ Gauze, 4x4 16 Ply, RFID, Double XRAY; Electronic Surgical Sponge-Counter

Catalog Number	0632-244-160
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
I was reported that during a robotic abdominal procedure, a 4 x 4 ray-tec sponge visibly frayed and the radiopaque marker began to separate from the sponge.Upon removal, multiple fragments of frayed sponge material were found to have detached and remained within the patient¿s abdomen.The procedure was converted to an open abdominal approach due to unrelated intraoperative complications, which allowed the surgical team to irrigate and inspect the abdominal cavity and remove all visible fragments before closure.

• Brand Name: SurgiCount+ Gauze, 4x4 16 Ply, RFID, Double XRAY
• Common Device Name: Electronic Surgical Sponge-Counter
• 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: kelsey barla ; 1941 stryker way; portage, MI 49002 ; +1(269)323-7700
• MDR Report Key: 50070606
• Report Number: 3015967359-2026-00451
• Device Sequence Number: 10287583
• Product Code: GDY
• UDI-Device Identifier: 07613327512649
• UDI-Public: (01)07613327512649
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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?: No
• Device Catalogue Number: 0632-244-160
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/29/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown