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

Model Number	E2750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Damage (2104); Blood Loss (2597)
Date of Event	07/04/2018
Type of Reportable Event	Serious Injury
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 choledocholithotomy, the handset and the electrode were used, and those were repeatedly in and out of 5mm trocar.However, suction was suddenly disabled.The shaft was checked and it was found damaged about 2cm of the shaft next to l hook electrode.New device was used, but then the electrode had dent upon retracting, and liver was damaged.Nothing fell into patient's cavity.Oozing bleeding less than 200cc, no transfusion was necessary.No further information available at this time.
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 choledocholithotomy, the handset and the electrode were used, and those were repeatedly in and out of 5mm trocar.However, suction was suddenly disabled.The shaft was checked and it was found damaged about 2cm of the shaft next to l hook electrode.New device opti4 spatula was used, but then the electrode had dent upon retracting, and liver was punctured.Treatment done to liver injury by cauterized and electrocautery.Nothing fell into patient's cavity.Oozing bleeding less than 200cc, no transfusion was necessary.No further information available at this time.
Additional Manufacturer Narrative
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: 7713610
• Report Number: 1717344-2018-00958
• Device Sequence Number: 995687
• Product Code: GEI
• UDI-Device Identifier: 10884524000435
• UDI-Public: 10884524000435
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2018

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 Model Number: E2750
• Device Catalogue Number: E2750
• Device Lot Number: 7140116X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 07/26/2018; 08/08/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/10/2018; 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OPTI4 SPATULA
• Outcome Attributed to Adverse Event: Other