MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LOOP T-BAR ELECTRODE W20 D15; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703320015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a large loop excision of the transformation zone(lletz) surgical procedure, the loop electrode broke while cutting.It was also reported there were no delays and no adverse consequences as a result of this event.It was also reported the procedure was completed successfully.
Additional Manufacturer Narrative
The reported event, for electrode breakage, was not confirmed as the electrode was not returned for evaluation.Without the electrode, the root cause cannot be determined.
Event or Problem Description
It was reported that during a large loop excision of the transformation zone(lletz) surgical procedure, the loop electrode broke while cutting.It was also reported there were no delays and no adverse consequences as a result of this event.It was also reported the procedure was completed successfully.

• Brand Name: LOOP T-BAR ELECTRODE W20 D15
• 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: 7870450
• Report Number: 0001811755-2018-01644
• Device Sequence Number: 19317426
• Product Code: GEI
• UDI-Device Identifier: 37613327297899
• UDI-Public: 37613327297899
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K153679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

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: 05/01/2019
• Device Catalogue Number: 0703320015
• Device Lot Number: REF 0703320015LOT 1620031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1