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

Model Number	E2750
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One e2750 was received for evaluation.Evaluation of the incident device did not confirm the reported event.An electrode was inserted into the handset and the grey collet was tightened.The electrode was held securely in the collet and could not be pulled out without effort.The electrode did not fit loosely.The devices functioned normally when activated with the generator.The investigation found the device to function normally and within specifications.No conditions were identified that would have caused or contributed to the reported event.The instructions for use state that when installing the electrode, loosen the handset lock nut by turning the nut counterclockwise.Insert the electrode shank into the nose of the handswitch.Tighten the lock nut by turning the nut clockwise until the arrows on the handset body and lock nut are aligned.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 during the procedure, the device was used as indicated but the shaft disengaged from the pencil grip.The shaft was connected to the grip but easily disengaged.A new pencil grip was used to continue.There was no patient harm.Nothing fell into the patient cavity.

• 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: 6598921
• Report Number: 1717344-2017-05369
• Device Sequence Number: 739830
• Product Code: GEI
• UDI-Device Identifier: 20884524000432
• UDI-Public: 20884524000432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K964175
• 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
• Report Date (Section B): 05/08/2017

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: 10/02/2021
• Device Model Number: E2750
• Device Catalogue Number: E2750
• Device Lot Number: 62740115X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1