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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM TENACULUM FORCEPS; ENDOSCOPIC INSTRUMENT

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INTUITIVE SURGICAL,INC. 8 MM TENACULUM FORCEPS; ENDOSCOPIC INSTRUMENT Back to Search Results
Model Number 470207-08
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/12/2017
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.The instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing from clevis in the 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 total bening hysterectomy procedure, the tenaculum forceps instrument would not hold jaws closed on tissue.Upon removal and inspection, the customer noted that the pulley cable had broken.While cleaning the instrument, a cable fragment was dislodged from instrument.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 TENACULUM FORCEPS
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 Key7003749
MDR Text Key92173874
Report Number2955842-2017-00751
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874112366
UDI-Public(01)00886874112366(10)S10170103
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 10/26/2017
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 Number470207-08
Device Lot NumberS10170103 0008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/26/2017
Initial Date FDA Received11/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2017
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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