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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM SMALL GRASPING RETRACTOR; ENDOSCOPIC INSTRUMENT

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INTUITIVE SURGICAL,INC. 8 MM SMALL GRASPING RETRACTOR; ENDOSCOPIC INSTRUMENT Back to Search Results
Model Number 470318-08
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure.To clarify the instrument failed engagement due to the instrument having a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing from clevis.The clevis did not exhibit any damage or wear marks.Other cables at the wrist were not damaged.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to this reported event.The customer reported complaint does not itself constitute an mdr reportable event; however, the broken pitch cable found during failure analysis suggests that if the malfunction were to recur it could cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the small grasping retractor instrument fired once and then stopped.There was no report of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.
 
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Brand Name
8 MM SMALL GRASPING RETRACTOR
Type of Device
ENDOSCOPIC INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
950 kifer rd
sunnyvale CA
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 
4085232420
MDR Report Key7278684
MDR Text Key100523777
Report Number2955842-2018-00103
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874112441
UDI-Public(01)00886874112441(10)S10170525
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 02/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number470318-08
Device Lot NumberS10170525 0072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/07/2018
Initial Date FDA Received02/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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