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

Model Number	E2781RS
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2018
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 laparoscopic oophorectomy and salpingectomy, the connection part between the electrode and pencil was loose and it would come out.The surgeon tried tightening the connection, but the looseness did not change.Another similar device was opened to complete the procedure.Nothing fell into patient's cavity.Surgical time was not extended.There was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.The reported condition was not confirmed.The investigation found that there was no missing component.The device was plugged into a 40k ohm test box and activated in both the cut and coag mode with satisfactory results.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7813163
• Report Number: 1717344-2018-01126
• Device Sequence Number: 11344028
• Product Code: GEI
• UDI-Device Identifier: 10884524000701
• UDI-Public: 10884524000701
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944244
• 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
• Report Date (Section B): 12/02/2018

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 Model Number: E2781RS
• Device Catalogue Number: E2781RS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1