MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 5MM BALL ELECTRODE; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703120005
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that after a surgical procedure, the user put the device on top of the drape and the drape started to burn.It was also reported that there were no delays, no patient involvement and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the device was not returned for investigation.The quality investigation is complete.
Event or Problem Description
It was reported that after a surgical procedure, the user put the device on top of the drape and the drape started to burn.It was also reported that there were no delays, no patient involvement and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 5MM BALL ELECTRODE
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8147942
• Report Number: 0001811755-2018-02719
• Device Sequence Number: 11138485
• Product Code: GEI
• UDI-Device Identifier: 37613327297806
• UDI-Public: 37613327297806
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: 0703120005
• Device Lot Number: 16220031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1