MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE VALVE ONLY

Catalog Number	828800PL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
The physician reported the certas plus inline valve (828800pl) failed and had to be replaced.No additional information has been received.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The certas plus inline valve (828800pl) was returned for evaluation.Device history record (dhr) - or the product code 82-8800pl with lot 7456068 conformed to the specifications when released to stock.Failure analysis - -the position of the cam when valve was received was at setting 1.The valve was visually inspected, and no defect was noted.The valve passed the test for programming, occlusion, leak, reflux and pressure.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the reported issue could be due to biologicals debris.Accumulation of biological matter within the valve can cause difficulties adjusting the valve setting with the tool kit and impair the anti-reflux function.

• Brand Name: CERTAS PLUS INLINE VALVE ONLY
• Common Device Name: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22864249
• Report Number: 3013886523-2025-00214
• Device Sequence Number: 12670455
• Product Code: JXG
• UDI-Device Identifier: 10381780535362
• UDI-Public: (01)10381780535362(11)240912(17)290831(10)7456068
• Combination Product (Y/N): N
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 828800PL
• Device Lot Number: 7456068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown