MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Model Number	E1562
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The return of the incident sample has been requested.To date, it has not been received for evaluation.Additional questions in regard to the incident have been asked.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The customer reported that the loop electrode snapped at edge.There was a fair amount of tissue loss.Additionally, there was more than 500cc of bleeding but no transfusion was needed.The area was sutured.The patient is stable.
Additional Manufacturer Narrative
One e1562 loop electrode was received for evaluation.Visual inspection found the wire loop to have broken.The customer reported a forcefxc generator with coag output at 70 was used during the procedure.According to the instructions for use, covidien recommends a maximum power setting of 55w cut for this type of electrode.This type of electrode should never be used in the coagulation mode.The investigation identified the root cause of the reported event to be user misuse by exceeding recommended power setting and using the device in the coagulation mode.The ifu states loop electrodes are not designed for use in the coagulation mode.Do not activate the generator in coag while using a loop electrode.Loop breakage may result.Exceeding maximum power setting may result in patient injury or product damage.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the loop electrode snapped at edge during a leep procedure.A forcefxc generator with coag output at 70.There was a fair amount of tissue loss.Additionally, there was more than 500 cc of bleeding but no transfusion was needed.The area was sutured.The patient is stable.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 6433383
• Report Number: 1717344-2017-05144
• Device Sequence Number: 10900217
• Product Code: HGI
• UDI-Device Identifier: 20884524000180
• UDI-Public: 20884524000180
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K931338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2017

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 Expiration Date: 08/01/2020
• Device Model Number: E1562
• Device Catalogue Number: E1562
• Device Lot Number: 0816BX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided; 05/09/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 06/01/2017; 09/06/2017
• 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: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 64