MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 VALVE 5/20; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	FX210T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a gav 2.0 valve 5/20 (part # fx210t) was implanted during a primary procedure performed on an unknown date.According to the complainant, the valve was suspected of being occluded.The patient underwent a revision procedure on an unknown date.The complaint device has not been returned to the manufacturer for evaluation.Although requested, additional information has not been made available.At this time, there is limited information as to method of intervention performed to resolve the blockage.The malfunction is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Manufacturing and quality control data: no manufacturer data are available, because no product data were submitted.Probably the products were finally tested as article fx210t and released for packaging and sterilization and was sterilized by miethke.Apart from the article number, we have no further traceability data (because missing product data).Each valve has a fixed pressure of 5 cmh2o in the horizontal and 20 cmh2o in the vertical position.Results: an investigation was not possible because the products were not returned.With reference to the reason for the complaint, we would like to point out that deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of non-visible deposits/proteins might compromise the integrity of the valve and could be an explainable reason for a possible blockage.Unfortunately, due to the missing sample, we are unable to provide a meaningful analysis.Based on the current information, no further regulatory actions are required from our point of view.
Event or Problem Description
No updates needed.

• Brand Name: GAV 2.0 VALVE 5/20
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12844105
• Report Number: 2916714-2021-00211
• Device Sequence Number: 4317477
• Product Code: NWV
• UDI-Device Identifier: 04041906500009
• UDI-Public: 4041906500009
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021
• Report Date (Section F): 11/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX210T
• Device Catalogue Number: FX210T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/19/2021