MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP; MESH, SURGICAL, COLLAGEN, STAPLE LINE REINFORCEMENT

Model Number	PSDA60GIATHN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
I was reported the patient experienced a gastric sleeve leak in conjunction with peri-strips.The patient underwent robot-assisted gastric/bariatric surgery where a non-baxter stapler and had ¿good results.¿ however, the gastric leak was observed and the surgeon switched to a different non-baxter surgical stapler.No further information was available at the time of this report.
Additional Manufacturer Narrative
H11: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP
• Common Device Name: MESH, SURGICAL, COLLAGEN, STAPLE LINE REINFORCEMENT
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SAINT PAUL; 2575 university ave w.; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24552457
• Report Number: 1416980-2026-00888
• Device Sequence Number: 5662304
• Product Code: OXE
• UDI-Device Identifier: 00085412658841
• UDI-Public: (01)00085412658841
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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
• Operator of Device: Health Professional
• Device Model Number: PSDA60GIATHN
• Device Catalogue Number: PSDA60GIATHN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTUITIVE SURGICAL STAPLER.; MEDTRONIC POWER STAPLER.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown