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

MAUDE Adverse Event Report: STRYKER CORPORATION MONOPOLAR ELECTROSURGICAL PROBE LAPAROSCOPE, GENERAL & PLASTIC SURGERY

  • 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
 

STRYKER CORPORATION MONOPOLAR ELECTROSURGICAL PROBE LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 250-040-112
Device Problems Insulation (473); Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2019
Event Type  Malfunction  
Event Description

A laparoscopic procedure started. The surgeon was using a non-disposable hook cautery (probe electrosurgical l-tip 5mm 33cm) from the lap basic tray 6 assembled by car. Upon using the hook, it was noticed the hook was cauterizing from the hook, as well as about 1 inch below the hook, leaving sporadic cautery marks on the patient. Upon inspection of the device, it was noticed that the insulation was cracked about an inch below the hook. Stryker reps were notified, and the device removed from service. A new hook cautery was opened and used. Manufacturer response for probe electrosurgical l-tip 5mm 33cm, (brand not provided) ,(per site reporter). Stryker reps were notified, and the device removed from service.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMONOPOLAR ELECTROSURGICAL PROBE
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER CORPORATION
5900 optical ct
san jose CA 95138
MDR Report Key8832302
MDR Text Key152378206
Report Number8832302
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 06/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250-040-112
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/04/2019
Event Location Hospital
Date Report TO Manufacturer07/26/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-