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	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event, for electrode breakage, was confirmed following a review of photographic evidence provided.The electrode was not available for return.Without the electrode, the root cause cannot be determined.Discarded by customer.
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: 7838514
• Report Number: 0001811755-2018-01634
• Device Sequence Number: 13832325
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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 Catalogue Number: 0703320015
• Device Lot Number: (01)07613327297898)(17)190510(
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1