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

Model Number	E2781RS
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
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 a laparoscopic lower anterior resection, the electrode broke.The device was mainly used for cutting during dissection of ligament and layers.For controlling bleeding, soft coagulation mode was used with opti4.The issue was noticed 2 hours later, during the procedure when the opti4 was placed on an instrument tray after use, and the electrode tip was found disengaged from the shaft and fell on the tray.The device was not in contact with other devices, or excess load was applied to the electrode tip.A new device was opened to continue.There was no patient harm.
Additional Manufacturer Narrative
Evaluation summary the product was not returned, however, a picture was provided by the customer for analysis.This device had been used in the treatment or diagnosis of a patient.Without the original packaging or a reported lot number, the investigator cannot determine if the product was within the assigned expiration date at the time of reported incident.The returned product did not meet specification as received.Visual inspection of the pictures found the tip of the electrode to have broken off.The reported condition was confirmed by the pictures.The inspection of the pictures showed that the tip broke off.The broken tip was also shown in the pictures.The picture of the fractured section indicated a stress fracture.The investigation of the pictures identified the root cause of the reported event to be the customer applying excessive force to the electrode tip.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: 7454912
• Report Number: 1717344-2018-00559
• Device Sequence Number: 962685
• 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): 06/11/2018

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?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1