MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Catalog Number	828804PL
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
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
1 of 2 reports (same failure, different patients).Other mfg report number: 3013886523-2025-00132.A facility reported that after implantation of a certas valve and after connecting the distal and peritoneal catheters, the surgeon was unable to get a flow to confirm the function of the valve.The procedure was completed with a replacement product available.No patient injury reported, however, and the event led to 30 minutes surgical delay.
Additional Manufacturer Narrative
The certas valve (id 828804pl) was returned for evaluation.Device history record (dhr) - product code 82-8804pl with lot 7508370, conformed to specifications when released to stock.Failure analysis - the position of the cam when the valve was received was at setting 3.The valve was visually inspected; no defect was noted.The valve was irrigated: excessive pressure was required to flush the valve ("valve popping").The valve was hydrated.The valve passed the test for programming, occlusion, leak, reflux, siphon guard and pressure.Root cause analysis - the possible root cause for the issue reported by the customer could have been due to after steam sterilization the ruby ball sticks to the ruby seat and potential effects of failure include ¿excessive pressure required to flush the valve pre-procedure ("valve popping")¿ as noted in the ifu.
Event or Problem Description
N/a.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Common Device Name: CERTAS PLUS W/ SG
• 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: 22158997
• Report Number: 3013886523-2025-00131
• Device Sequence Number: 20674874
• Product Code: JXG
• UDI-Device Identifier: 10381780535409
• UDI-Public: (01)10381780535409(17)291231(10)7508370
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 828804PL
• Device Lot Number: 7508370
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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
• Patient Sex: Unknown