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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI TIP COVER ACCESSORY

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INTUITIVE SURGICAL, INC DA VINCI TIP COVER ACCESSORY Back to Search Results
Model Number 400180-14
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/02/2020
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the monopolar curved scissors (mcs) tip cover accessory involved with this complaint and completed the device evaluation. Failure analysis investigation replicated/confirmed the customer reported complaint of ¿split extending into the dark gray plastic¿. The mcs tip cover accessory was found to have tearing at the mouth on the distal end. Tears were axially aligned with the mcs tip cover accessory, measured 0. 180¿ in length and reached the gray silicone area. There were no signs of thermal damage present at the end of any tears. Tears at the mouth are most commonly caused by repeated thermal and mechanical stress. System log review: the part #400180-14/lot #m91191108 does not show in the logs due to part being an accessory. Therefore, an instrument log review of the product related to the complaint cannot be performed at this time. No image or video clip for the reported event was submitted for review. No other complaints related to this event have been reported. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the mcs tip cover accessory had a tear on the gray part of the accessory, which could lead to arcing. Although no arcing was seen and no patient harm, adverse outcome or injury occurred, if this malfunction were to recur it could cause or contribute to an adverse event. In addition, the mcs tip cover accessory fell inside of the patient during the mcs instrument removal from the patient. All fragments were retrieved and no additional surgical intervention was required. However, unintended fragments falling inside the patient may require surgical intervention. At this time, it is unknown what caused the mcs tip cover accessory to fall inside of the patient.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, a split was extending into the darker gray plastic on the monopolar curved scissors (mcs) tip cover accessory. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the da vinci coordinator and obtained the following additional information: the mcs instrument and the mcs tip cover accessory were inspected prior to use and no damage was noted. The mcs instrument and the mcs tip cover accessory were in use approximately four hours intermittently, and then a tear on the was noted on the mcs tip cover accessory. While the mcs instrument was being removed from the patient, the mcs tip cover accessory fell inside of the patient having possibly gotten caught on the cannula. The mcs tip cover accessory was retrieved with a laparoscopic instrument. There was no mcs instrument functionality issue noted. It is unknown if the mcs instrument collided with any other instruments, if the surgical staff felt any resistance upon removal of the instrument through the cannula, or if the instrument wrist was straightened upon removal. The surgical staff did not notice any damage to the mcs instrument or cannula after the event occurred. The mcs tip cover accessory was appropriately installed with an installation tool and no electrolube was used. It was also confirmed that the mcs tip cover accessory was not installed beyond the orange surface. No photographic image or video recording of the procedure were available.
 
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Brand NameDA VINCI
Type of DeviceTIP COVER ACCESSORY
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key10215881
MDR Text Key230622539
Report Number2955842-2020-10617
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180-14
Device Catalogue Number400180
Device Lot NumberM91191108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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