MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Model Number IS3000 A6.0P6

Device Problem Difficult To Position (1467)

Patient Problems Death (1802); Bowel Perforation (2668)

Event Date 10/11/2012

Event Type  Death  

Event Description

It was reported 2 days post a successful da vinci si myomectomy procedure, the patient expired. The intuitive surgical clinical sales representative (csr) that reported this incident indicated that on (b)(6) 2012, the surgeon who performed the surgical procedure reported to him that a tenaculum forceps instrument being used during the surgical procedure was not moving as it should. The csr indicated that he instructed the surgeon to have the instrument removed, cleaned and re-installed. The csr indicated that the site proceeded using the instrument and the planned surgical procedure was completed. No patient harm, adverse outcome or injury was reported to have occurred at the time of the surgical procedure. On (b)(6) 2012, the intuitive surgical csr was notified by the surgeon that the patient was re-admitted to the hospital on (b)(6) 2012 due to a perforated bowel and the patient expired on (b)(6) 2012. The csr indicated that the surgeon indicated the surgical procedure went fine. The surgeon indicated to the csr that a video recording of the surgical procedure is not available and that the cause of the patient's injury is unknown. Late submission of the medwatch report is due to an reporting oversight by the responsible complaint handler.

Manufacturer Narrative

On (b)(6) 2012 an inspection of the site's system was performed by an intuitive surgical field service engineer(fse). Inspection of the site's da vinci si surgical system by the fse found no issues and that the site's system functioned within specification. The site has indicated to the intuitive surgical clinical sales representative that the site is currently performing an internal investigation into the reported incident and is unable to provide any other details concerning the incident. Several attempts have been made to verify additional details concerning the reported event; however, no additional information was provided. A follow-up mdr will be submitted if additional information is received.

• Brand Name: DA VINCI SI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 1266 kifer rd, bldg 101; sunnyvale CA 9408 6
• Manufacturer Contact: tabitha reed ; 1266 kifer rd, bldg 101; sunnyvale, CA 94086
• MDR Report Key: 2890369
• MDR Text Key: 3060928
• Report Number: 2955842-2012-01482
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (Y/N): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/11/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/29/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: IS3000 A6.0P6
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/11/2012
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 07/01/2010
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 12/29/2012 Patient Sequence Number: 1

Treatment

DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES