MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCETRIAD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	FT0021S
Medical Device Problem Codes	Arcing (2583); Flare or Flash (2942); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Blood Loss (2597)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during a procedure, the device had an issue with the loop.After connecting a resectoscope, a blazing sound was heard from the cable tip during a second activation.Sparking was also noted.The issue resulted in damage to the surgeons hand and a burn to the tip of the patient's urinary opening.The patient experienced between 250-500 cc's of bleeding, requiring a transfusion.The patient also had a second degree burn on the wall of the surgical site, requiring additional surgical treatment.Another device was used to complete the procedure.The issue caused patient hospitalization to be extended by three additional days.
Additional Manufacturer Narrative
Evaluation summary: the incident sample was not returned for evaluation however, a picture sample for the impacted lot was returned by the customer.This picture sample was sent to the supplier for evaluation.No failure mode was identified with the picture sample.The instructions for use was reviewed and found to include warnings that the cord should be inspected before and after each use for cracks, nicks, cuts, dents, or depressions which may decrease the insulation effectiveness.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FORCETRIAD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7036264
• Report Number: 1717344-2017-06241
• Device Sequence Number: 1144897
• Product Code: GEI
• UDI-Device Identifier: 20884521062082
• UDI-Public: 20884521062082
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K110268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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 Model Number: FT0021S
• Device Catalogue Number: FT0021S
• Device Lot Number: U148X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 01/25/2018
• 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: Hospitalization; Required Intervention