MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LOOP T-BAR ELECTRODE W10 D10; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703310010
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device was discarded.
Event or Problem Description
It was reported that during a lletz (large loop excision of the transformation zone) procedure, the electrode tip caught fire.It was also reported that the electrode tip was used with a competitor pencil.It was further reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
B5: it was also reported that the electrode tip was past its expiry date when used.H6: the device was not returned for investigation.The quality investigation is complete.
Event or Problem Description
It was reported that during a lletz (large loop excision of the transformation zone ) procedure, the electrode tip caught fire.It was also reported that the electrode tip was used with a competitor pencil.It was further reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.It was also reported that the electrode tip was past its expiry date when used.

• Brand Name: LOOP T-BAR ELECTRODE W10 D10
• 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: 9607616
• Report Number: 0001811755-2020-00099
• Device Sequence Number: 16824617
• Product Code: GEI
• UDI-Device Identifier: 37613327297905
• UDI-Public: 37613327297905
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K153679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 12/01/2019
• Device Catalogue Number: 0703310010
• Device Lot Number: 1650011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1