MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR OSV II

Catalog Number	909708S
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
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
A facility reported that during implantation of ventriculoperineal diversion system, the surgeon observed that the osv ii valve (909708s) was leaking when he wanted to fix the system.A tear was discovered on the valve.There was increased surgery/anesthesia time of 30 minutes; however, there was no consequence for the child patient as the defect was observed during fixing.
Additional Manufacturer Narrative
The osv ii valve (909708s) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and conformed to the specifications when released to stock.Failure analysis - the investigation of the returned valve confirmed the complaint: air and water permeability tests were done on the valve and the results failed.The valve was visually inspected, and a cut mark was noted.The cut was analyzed, a leak test was done, and the valve was leaking.Root cause - the root cause could be due to improper handling of the device in view of the cut on the back of the device or due to a sharp or pointed object coming into contact with the valve in view of the cut marks on the valve.No manufacturing, workmanship, or material deficiency was identified; thus, no corrective action is required.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: OSV II
• Common Device Name: OSV II
• 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 ; 6099362319
• MDR Report Key: 18897081
• Report Number: 3013886523-2024-00074
• Device Sequence Number: 12683297
• Product Code: JXG
• UDI-Device Identifier: 10381780035480
• UDI-Public: 10381780035480
• Combination Product (Y/N): N
• PMA/510(K) Number: K971799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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 Expiration Date: 11/25/2024
• Device Catalogue Number: 909708S
• Device Lot Number: 0226662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• 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