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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

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INTUITIVE SURGICAL,INC. PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT Back to Search Results
Model Number 420183-05
Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 02/20/2013
Event Type  Injury  
Manufacturer Narrative
\the instrument was returned and evaluated. Per the customer reported complaint, engineering evaluation results confirmed the alleged issue of a pulled off hook tip. The instrument was returned to isi with the hook detached from the distal end. The hook was found to be fractured within the yaw pulley, at the cross section of one of the holes in the shank. \engineering evaluation also found a broken ceramic sleeve and tube damage. The entire ceramic sleeve was missing from the yaw pulley. In addition, the distal end of the instrument's main tube was observed to have various scratch marks with light material removal. The scratches were. 070 -. 160 in length and not aligned with the instrument's tube axis. Engineering evaluation concluded that the damages were likely due to mishandling/misuse. The instruments and accessories user manual specifically states: general precautions and warnings - handle instruments with care. Avoid mechanical shock or stress that can cause damage to the instruments. Do not use an instrument to clean debris from another instrument intraoperatively. This may result in damage to the instruments or other unintended consequences, such as disconnection of the instrument tip. On (b)(4) 2013, isi contacted the initial reporter of this complaint and obtained additional information. The initial reporter indicated that a c-arm was used to help locate the tip fragment. The fragment was reportedly retrieved through one of the current port incisions. The initial reported stated that no extra surgical procedures were performed. According to the initial reporter, the planned lar procedure was completed as planned and no post-operative complications occurred.
 
Event Description
It was reported that during a da vinci si low anterior resection procedure, the hook at the tip of the permanent cautery hook instrument was pulled off and fell into the patient. The fragment was reportedly retrieved and the planned surgical procedure was completed.
 
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Brand NamePERMANENT CAUTERY HOOK 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 Key3017496
MDR Text Key10605851
Report Number2955842-2013-00943
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 02/20/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420183-05
Device Lot NumberM10100505 372
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2013
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received02/20/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2010
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: 03/22/2013 Patient Sequence Number: 1
Treatment
DA VINCI SI SURG SYS INST., ACCESSORIES, & ESU
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