MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LOOP T-BAR ELECTRODE W20 D20; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703320020
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/13/2018
Type of Reportable Event	Serious Injury
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 during a lletz (large loop excision of the transformation zone) procedure, the loop t-bar electrode burnt and a replacement was used to complete the procedure.It was also reported that during a follow up visit, the patient informed the surgeon that she received a second degree burn to the right gluteal region, 10cm in length, which is currently healing without treatment but is expected to leave a scar.
Additional Manufacturer Narrative
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 loop t-bar electrode burnt and a replacement was used to complete the procedure.It was also reported that during a follow up visit, the patient informed the surgeon that she received a second degree burn to the right gluteal region, 10cm in length, which is currently healing without treatment but is expected to leave a scar.

• Brand Name: LOOP T-BAR ELECTRODE W20 D20
• 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: 7971641
• Report Number: 0001811755-2018-01746
• Device Sequence Number: 13503107
• Product Code: GEI
• UDI-Device Identifier: 37613327297868
• UDI-Public: 37613327297868
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0703320020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other