MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY COAGULATING BIPOLAR ELECTRODE

Model Number 28762KB

Device Problem Arcing of Electrodes (2289)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation confirmed that the distal end teflon is burned, melted and cracked.Also the shaft is bent, and the proximal end label is illegible.The instrument has a date code of sx(05/2012) and it has been in use for approximately 5 years.Damage is consistent with wear of long use/stress overload.

Event Description

Allegedly, during a ventriculostomy procedure the doctor noted that the instrument sparked during the procedure.The instrument was immediately replaced and the procedure was completed with no delay.The hospital reported there was no serious injury to patient.

Event Description

This is a supplemental.I listed the wrong part number in the mdr.I listed 28162kb; it should be 28762kb.I also added udi #.I will make correction.

• Brand Name: COAGULATING BIPOLAR ELECTRODE
• Type of Device: COAGULATING BIPOLAR ELECTRODE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 6367127
• MDR Text Key: 68969162
• Report Number: 9610617-2017-00019
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 28762KB
• Device Catalogue Number: 28762KB
• Device Lot Number: SX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 56 YR