MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. EASY CHECK FETAL SCALP BLOOD SAMPLER KARL STORZ SE; ENDOSCOPE, FETAL BLOOD SAMPLING (AND ACCESSORIES)

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2021

Event Type  Injury  

Event Description

Fetal scalp blood sampler from karl storz se.As clinical reviewer i found out that the risk associated with that product no longer justify the benefits, if any benefit at all.The manufacturer submitted a clinical evaluation for three years, ignoring the clinical data without providing action, which let to further cases.I need to provide the agency with my report, so 4000 character are not sufficient, provide an email to report that case adequately.Fda safety report id # (b)(4).

• Brand Name: EASY CHECK FETAL SCALP BLOOD SAMPLER KARL STORZ SE
• Type of Device: ENDOSCOPE, FETAL BLOOD SAMPLING (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.
• MDR Report Key: 11797125
• MDR Text Key: 250068230
• Report Number: MW5101257
• Device Sequence Number: 1
• Product Code: HGK
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability