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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY

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INTUITIVE SURGICAL,INC. TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY Back to Search Results
Model Number 400180-14
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/20/2017
Event Type  Injury  
Manufacturer Narrative
On (b)(4) 2018, intuitive surgical, inc. (isi) received the following additional information regarding the reported event: the monopolar curved scissors (mcs) tip cover accessory detached during the da vinci-assisted surgical procedure and remained in the wall of the patient's abdomen. As a result, the surgeon made the decision to convert to a mini-laparotomy procedure in order to retrieve the mcs tip cover accessory. No additional anesthesia was administered. Upon further review and investigation of this complaint, intuitive surgical, inc. (isi) has determined that some of the information provided within the initial mdr was partially incorrect. The mcs tip cover accessory was not returned to isi for evaluation. Therefore, the root cause of the customer reported issue cannot be determined. The mcs instrument (part 470179-14; lot n10170406-0031) involved with this complaint was returned to isi and evaluated. The instrument's tube extension was found to be broken. The damaged area measured approximately 0. 224 x 0. 287. A broken off piece was not returned with the instrument. The known common cause of the failure is due to mishandling/misuse. The instrument tube extension was inspected for cracks and there were no cracks found. Isi has reviewed the site's system logs with a procedure date of (b)(6) 2017. No related system errors were found to have occurred during the surgical procedure. Also, the system logs reveal that the mcs instrument involved with the reported event was actually used in subsequent da vinci-assisted surgical procedure performed on (b)(6) 2017. During that surgical procedure, another mcs tip cover accessory allegedly fell off inside the patient but was retrieved during the same surgery. Refer to mfr report 2955842-2018-00032 (patient identifier (b)(6)) for this second reported event. This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the mcs tip cover accessory, installed on a mcs instrument, allegedly fell inside the patient. In order to retrieve the mcs tip cover accessory, the case was converted to a mini-laparotomy procedure. However, at this time, the root cause of the customer reported issue is unknown.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors (mcs) tip cover accessory allegedly became detached upon removal of the mcs instrument. The mcs tip cover accessory remained in the patient's abdomen and the case was converted to a mini-laparotomy procedure to retrieve the instrument accessory. The mcs tip cover accessory was not available for return to intuitive surgical, inc. (isi) for evaluation.
 
Manufacturer Narrative
The mcs tip cover accessory was not returned to isi for evaluation. Therefore, the root cause of the customer reported issue cannot be determined. The mcs instrument was returned to isi and evaluated. The instrument's tube extension was found to be broken. The damaged area measured approximately 0. 224 x 0. 287. A broken off piece was not returned with the instrument. The known common cause of the failure is due to mishandling/misuse. The instrument tube extension was inspected for cracks and there were no cracks found. Isi has reviewed the site's system logs and determined that the mcs instrument involved with the reported event was last used on (b)(6) 2017, not (b)(6) 2017 based on follow-up information obtained on 12/08/2017. No related system errors were found to have occurred during the surgical procedure. This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the mcs tip cover accessory, installed on a mcs instrument, allegedly fell inside the patient. In order to retrieve the mcs tip cover accessory, the case was converted to a mini-laparotomy procedure. However, at this time, the root cause of the customer reported issue is unknown.
 
Event Description
It was initially reported that during a da vinci-assisted surgical procedure, the tip of the monopolar curved scissors (mcs) instrument allegedly slipped and fell inside the patient's abdomen. On 12/08/2017, intuitive surgical, inc. (isi) obtained the following additional information regarding the reported event from the site: the mcs instrument was inspected prior to use. No additional anesthesia was administered due to the reported instrument issue. The instrument tip was found and removed during the same surgical procedure which reportedly occurred on (b)(6) 2017. In addition, no post-operative complications were reported. On 12/12/2017, isi contacted the site and confirmed that the instrument tip that allegedly fell inside the patient's abdomen was actually a mcs tip cover accessory and not an instrument fragment. On 01/04/2018, isi received the following additional information regarding the reported event: in order to retrieve the mcs tip cover accessory, the surgeon made the decision to convert the da vinci-assisted surgical procedure to a mini-laparotomy. The mcs tip cover accessory is not available for return to isi for evaluation.
 
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Brand NameTIP COVER ACCESSORY
Type of DeviceENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY
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 Key7183929
MDR Text Key158779685
Report Number2955842-2018-00023
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180-14
Device Lot NumberM10170728
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/11/2018 Patient Sequence Number: 1
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