• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG NEEDLE,VERESS,PNEUMOPERITONEUM NEEDLE, VERESS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KARL STORZ SE & CO. KG NEEDLE,VERESS,PNEUMOPERITONEUM NEEDLE, VERESS Back to Search Results
Model Number 26120J
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Per the factory in germany, according to first risk assessment done by safety officer, there are no indications for a systemic problem. Product has not been returned for evaluation.

 
Event Description

Per the factory in (b)(6), allegedly, the tip of the veress needle broke off in the patient. No impact to patient or user described.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEEDLE,VERESS,PNEUMOPERITONEUM
Type of DeviceNEEDLE, VERESS
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen, gm,
Manufacturer (Section G)
KARL STORZ SE & CO.KG
dr.-karl-storz -strasse 34
78532
tuttlingen, gm,
Manufacturer Contact
susie chen
2151 e. grand avenue
el segundo, ca 
2188201
MDR Report Key9990276
MDR Text Key188676401
Report Number9610617-2020-00051
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK951251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 04/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number26120J
Device Catalogue Number26120J
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2020
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/23/2020 Patient Sequence Number: 1
-
-