MAUDE Adverse Event Report: COVIDIEN VA1LEYLAB ESU CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number UNKNOWN - VL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Discomfort (2330); Injury (2348); Abdominal Distention (2601)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment during a robotic assisted total laparoscopic hysterectomy with bilateral "salpingo-oophorectom".It was reported that during the procedure, the doctor over-sewed and caused a laceration or rupture in patient's bladder.The doctor converted the robotic hysterectomy to a vaginal hysterectomy surgery and largely concluded it in that manner.The patient experienced significant abdominal pain, distention, nausea and vomiting.A cystogram/radiology eventually confirmed a suspected intraperitoneal bladder rupture.The patient therefore needed a second, corrective surgery to repair her bladder.

• Brand Name: VA1LEYLAB ESU CABLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 5920 longbow drive; boulder CO 80301
• Manufacturer (Section G): COVIDIEN; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: lisa hernanadez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8209951
• MDR Text Key: 131843452
• Report Number: 1717344-2019-00013
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN - VL
• Device Catalogue Number: UNKNOWN - VL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR