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

Model Number IS3000 A6.0P8

Device Problem Detachment Of Device Component (1104)

Patient Problems Injury (2348); Prolapse (2475); Organ Dehiscence (2502)

Event Date 01/31/2011

Event Type  Injury  

Event Description

As part of a legal mediation effort on (b)(4) 2013 intuitive surgical received information regarding a patient who experienced post-surgical complications after undergoing a da vinci si hysterectomy for endometrial cancer on (b)(6) 2011. Per the information provided, there were no surgical complications experienced by the patient during da vinci hysterectomy procedure. Intra operative blood loss was reported to be 50cc. Reportedly, the patient's vaginal cuff was closed with running vicryl suture. Post operatively the patient had hyponatremia, which required some intravenous fluid hydration, but otherwise the patient did well and was discharged home in good condition. On (b)(6) 2011 the patient was seen by her doctor, and during her follow -up visit it was indicated that her vaginal cuff was well supported and intact with no tenderness. The patient was asked to follow up in with her doctor in six months. On (b)(6) 2011 the patient complained of vaginal pressure and she went to emergency room. The patient was not diagnosed with any significant issues and was discharged home with a recommendation of follow up. Allegedly, while on vacation, on (b)(6) 2011 while the patient was walking on the beach, she had an acute vaginal cuff dehiscence with prolapse of her small bowel to the knees. The patient was immediately rushed to the emergency room at a local hospital. On (b)(6) 2011 the patient underwent an emergency surgery for her condition. After being placed under anesthesia, the patient was manually reduced back to her intra-abdominal cavity, and the damage to her vaginal cuff was closed with interrupted vicryl sutures. Good hemostasis was noted. No other information was provided.

Manufacturer Narrative

Based in the information provided, intuitive surgical has not determined the root cause of the injury sustained by the patient. If additional information is received a follow up medwatch report will be submitted to the fda. Attempts have been made to gather additional information from the risk management group at the site, however as of the date of this report no response has been received. In addition, no previous complaint was reported relating to this event. Review of the site's system logs for the reported procedure date of (b)(6) 2011 found that no system errors were generated that would have caused or contributed to the injury sustained by the patient. This complaint is being reported due to the following conclusion: the patient experienced post-surgical complications after undergoing a da vinci si hysterectomy procedure.

• 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: 3305519
• MDR Text Key: 15201285
• Report Number: 2955842-2013-03136
• 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: Other,User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: IS3000 A6.0P8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/25/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2010
• 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: 08/23/2013 Patient Sequence Number: 1

Treatment

DAV SI SURG. SYSTEM INSTRUMENTS, ESU & ACCESS.