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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. MARYLAND BIPLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

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INTUITIVE SURGICAL,INC. MARYLAND BIPLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT Back to Search Results
Model Number 420179
Device Problem Self-Activation or Keying (1557)
Patient Problem Bowel Burn (1756)
Event Date 02/11/2013
Event Type  Injury  
Manufacturer Narrative
On (b)(4) 2013 an inspection of the site's da vinci si system conducted by an isi field service engineer (fse) was unable to replicate the cautery issue experienced by the site. Functional testing performed on the site's system by the fse found that the site's da vinci si surgical system functioned within specification. On (b)(4) 2013 isi contacted the isi clinical sales representative (csr) who reported this event. The csr indicated that she met with the operating room director and operating room scrub technician at the site on (b)(4) 2013 and the operating room scrub technician indicated to her that automatic activation of cautery energy was due to the surgical staff had incorrectly connected the electrical surgical unit (esu) cables into the improper receptacles on the esu. The scrub technician indicated that the esu connections were corrected, and the issue was resolved. The planned surgical procedure was completed. A general surgeon at the hospital was consulted to access the damage to the patient's bowel burn. The general surgeon's assesment of the burn to the patient's bowel determined that no repair of the affected area was required. On (b)(4) 2013, isi contacted the surgeon who performed the surgical procedure. The surgeon indicated that while he was retracting the patient's bowel using the maryland bipolar forceps instrument, he heard the alarm from the esu and immediately stopped using the maryland bipolar forceps instrument. The surgeon indicated that he had not touched the footpedal and that the instrument activated when he had not pressed the footpedal. The surgeon indicated that the patient sustained a small burn injury to the sigmoid colon and that he attempted to consult with a general surgeon concerning the patient's injury; however, there was no general surgeon available at that time. The surgeon indicated that he assessed the damage to the patient's bowel and he determined that the damage did not require any repair. The surgeon indicated that the patient remained in the hospital an additional day for monitoring and that the patient was discharged from the hospital. The surgeon indicated that the patient is recovering well and has not returned to the hospital due to experiencing any post-surgical complications as a result of the reported event. Intuitive surgical's instruments and accessories user manual precautions and warnings indicate: caution: please refer to the individual esu manufacturer's user manual for operating instructions. Warning: do not use monopolar instruments with a bipolar source output as this may cause damage to the instrument and harm to the patient or medical personnel. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.
 
Event Description
It was reported that during a da vinci si prostatectomy procedure, when the surgeon activated bipolar cautery energy from the footpedal on the surgeon side cart, cautery energy from the monopolar curved scissors (mcs) instrument was activated causing a burn to the patient's bowel.
 
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Brand NameMARYLAND BIPLAR FORCEPS INSTRUMENT
Type of DeviceENDOSCOPIC ELECTROSURGICAL INSTRUMENT
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 Key3024317
MDR Text Key10608315
Report Number2955842-2013-00977
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/25/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number420179
Device Lot NumberM10111118 819
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received02/25/2013
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2011
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: 03/27/2013 Patient Sequence Number: 1
Treatment
DAV SI SURG SYS., INSTRUMENTS, ACCESSORIES & ESU
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