MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE ELECTRODE; 878.4400 ELECTROSURGICAL CUTTING COAGULATION

Model Number 2000-00-11

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/12/2014

Event Type  malfunction  

Event Description

(b)(4).Event took place in (b)(6) and has not been reported to national hlth authorities.Summary of user's narrative from initial report: "during a cholecystectomy procedure the distal tip of the dissector broke apart.The broken tip has not been located and there is suspicion it was left inside the pt although x-rays did not locate the missing part.The pt has not shown any reactions and is doing well.".

Manufacturer Narrative

No specific corrective action due to mitigative prevention of hazards is assigned to this report.A review of the relevant device history records and the raw material history files did neither indicate recorded qual problems nor rejections related to this incident.If any further info is becoming available, mfr immediately will inform fda.If no further info is becoming available, mfr considers this file as closed.After evaluation of the data and evaluating the point of failure on the electrode, we assume that the damage to the electrode was caused by local conditions in the application.With the available data, a product failure cannot be confirmed.

• Brand Name: ELECTRODE
• Type of Device: 878.4400 ELECTROSURGICAL CUTTING COAGULATION
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-strasse 01; geisingen, baden-wurttemberg 7818 7; GM 78187
• Manufacturer Contact: christian quass, dir reg affairs ; karl-hall-strasse 01; 7049291586
• MDR Report Key: 4016111
• MDR Text Key: 22261297
• Report Number: 9611612-2014-00010
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K062047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2000-00-11
• Device Lot Number: LG
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2014
• Date Manufacturer Received: 06/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention