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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY

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INTUITIVE SURGICAL,INC. 8 MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY Back to Search Results
Model Number 400180
Event Date 08/07/2012
Event Type  Injury  
Manufacturer Narrative

Neither the tip cover accessory nor the monopolar curved scissors have been returned for evaluation, therefore, the root cause of the customer reported failure mode cannot be determined. The root cause of the surgical complication experienced by the patient is also currently undetermined. On (b)(6) 2012 the initial reporter indicated that the physician involved with this incident had made the determination that arcing had caused the damage; however this determination was made approximately 30 days after the procedure and after the patient had returned complaining of pain. The operating room staff and team did not observe any arcing during the procedure and could not confirm the physician's observation. Additionally, since the physician delayed reporting this arcing, the team could not isolate which instrument was used during the case. Isi was available to provide which monopolar curved scissor instrument was used during that case and has made an attempt to have this instrument returned. The tip cover accessory used with the case was not saved as it is disposable. The initial reporter explained that the physician did not have much experience and had done only a few of these surgeries. The operating room staff could not collaborate the physician's story and nothing abnormal was observed during the original case by the team. While monopolar curved scissors tip cover accessory was disposed of and was not available for return, however there was nothing abnormal observed with the tip cover during the case either.

 
Event Description

It was reported that after a successful da vinci si sacrocolpopexy procedure, the patient was discharged on day after her postoperative lleus resolved. On the 5th day the patient began experiencing abdominal pain and nausea. The next day the patient went in for emergency care, where she was identified as having a plain film of her abdomen showing free air. A ct scan was performed of the abdomen and pelvis which showed extravasation of contrast from the large bowel. General surgery returned the patient to the operating room to explore her abdomen and likely perform a colostomy. The patient required the mesh that was placed during the sacrocoplexy to be removed. During exploratory laparotomy, a 5mm perforation was identified in the sigmoid colon several centimeters distant from the area of operation. The defect in the colon was alleged to be consistent with a cautery injury. It is alleged that this injury is likely associated with arcing/cautery of the robotic instrument.

 
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Brand Name8 MM MCS TIP COVER ACCESSORY
Type of DeviceENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY
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 Key2781665
Report Number2955842-2012-00526
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/10/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number400180
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Hospital
Date Manufacturer Received09/10/2012
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/10/2012 Patient Sequence Number: 1
Treatment
DA VINCI SI SURGICAL SYSTEM, MCS INST., ACCS., ES
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