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

Model Number	E1559
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during conization, the loop electrode broke and was not recognized by the generator.Nothing fell into patient's cavity.A new device was used to continue the procedure.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional: evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection showed that the loop electrode was broken.The investigation found that the loop electrode was broken and so, the device was not detected by the generator.The loop can be broken due to mechanical damage by the user, or due to the user using abnormally high generator settings.The generator settings were not reported by the customer.The investigation identified the root cause of the reported event to be user.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: 7542676
• Report Number: 1717344-2018-00756
• Device Sequence Number: 1224444
• Product Code: HGI
• UDI-Device Identifier: 10884524000169
• UDI-Public: 10884524000169
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2018

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: 12/01/2021
• Device Model Number: E1559
• Device Catalogue Number: E1559
• Device Lot Number: X1217FX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/31/2018; 10/02/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 06/15/2018; 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1