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

Model Number	E2783-28
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found the top part of the extend/retract part of the device had separated.According to the reporter, device was difficult to assemble.The reported condition was confirmed.The investigation found the top part of the extend/retract part of the device had separated.This made extending or retracting the tip of the electrode very hard.Engineering reviewed the complaint device.The condition reported of being difficult to extend and retract the electrode was confirmed.When attempting to extend and retract the electrode the cap on the distal end separated from the slider mechanism which caused the difficult experienced by the user.The assembly is made by a supplier and this is considered a supplier caused defect due to lack of bonding chemicals on the cap.A lot number was not provided so it is unknown when this device was produced or what trace of electrode was used.The investigation identified the root cause of the reported event to be a supplier issue.A scar has been issued to the supplier.The failure identified is captured in section # 5 of the current risk management file.File # (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic choledocholithotomy, the device was stiff to get the electrode tip in and out and was difficult to use.They stopped using the device and completed the procedure by using another device.There was no patient injury.

• 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: 9385527
• Report Number: 1717344-2019-01556
• Device Sequence Number: 16699141
• Product Code: GEI
• UDI-Device Identifier: 10884524000565
• UDI-Public: 10884524000565
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K904560
• 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
• Report Date (Section B): 11/27/2019

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: E2783-28
• Device Catalogue Number: E2783-28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1