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

Model Number	E2783R-28ASP
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Blood Loss (2597); Bowel Perforation (2668)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: to date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy, the physician was attempting to retract the l-hook while the distal end of the electrode remained in the abdominal cavity.While attempting this, the electrode dislodged from the hand piece because the locking ring for the electrode did not lock into place.The reporter indicated that the locking ring did not fit properly into the hand piece.The resulting force that was applied to the hand piece was transferred to the electrode causing the tip to puncture the patient's liver bed, causing a loss of 150 cc of blood.The bleeding was controlled through the use of mechanical pressure using a sponge and instrument, followed by cauterization of the wound until hemostasis was achieved.This resulted in a delay of 15 minutes to the procedure.The patient injury was reported as temporary, with no further information provided.

• 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: 7061503
• Report Number: 1717344-2017-06283
• Device Sequence Number: 1358645
• Product Code: GEI
• UDI-Device Identifier: 10884524000725
• UDI-Public: 10884524000725
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2017
• Device Model Number: E2783R-28ASP
• Device Catalogue Number: E2783R-28ASP
• Device Lot Number: 245075X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Weight: 109