MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SET W/SPRUNG RESERVOIR MININAV 5; HYDROCEPAHLAUS MANAGEMENT

Model Number	FV713T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a prosa (part # fv713t) was to be implanted during a procedure performed on (b)(6) 2022.According to the complainant, the valve was not able to be adjusted.A new valve was able to be used, and the procedure was continued and successfully completed.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Investigation: visual inspection: a slightly deformation of the outer housing of the prosa valve was observed through the visual inspection.A measurement of the plane parallelism could confirm this.The prosa valve housing was subsequently measured and confirmed/indicated the presence of a deformation.The housing deformation measured at -0.055 mm, outside the tolerance of 0 ± 0.02 mm.Adjustment test: the prosa valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Results: it should be noted that the product was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.Based on our examination results, we cannot determine a malfunction of the valve at the time of our examination.How the mentioned functional impairment occurred is not clear to us at the time of the examination.The cause of the deformation of the prosa valve could not be determined through our investigation.Significant outside pressure, for example by too much force from the prosa adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required from our point of view.

• Brand Name: PROSA SET W/SPRUNG RESERVOIR MININAV 5
• Common Device Name: HYDROCEPAHLAUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 13549843
• Report Number: 3004721439-2022-00025
• Device Sequence Number: 5257019
• Product Code: JXG
• UDI-Device Identifier: 04041906133955
• UDI-Public: 4041906133955
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

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: 08/02/2026
• Device Model Number: FV713T
• Device Catalogue Number: FV713T
• Device Lot Number: 20054685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown