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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST MEGA SUTURECUT ND

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INTUITIVE SURGICAL, INC ENDOWRIST MEGA SUTURECUT ND Back to Search Results
Model Number 471309-15
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2022
Event Type  Injury  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has not received the mega suturecut needle driver instrument for evaluation. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received. A review of the site's complaint history does not show any additional complaints related to this product. No image or video clip for the reported event was submitted for review. A review of system and instrument log was performed. The instrument was last used on (b)(6) 2022 on system sl0215 for 0:12:30 sec. The mega suturecut needle driver has 0 uses remaining after last use. The instrument has max 15 uses. This complaint is being reported due to the following conclusion: it was alleged that the instrument broke inside the patient during a da vinci assisted procedure. The customer reported that it was unknown if any fragments fell inside the patient as a result of the breakage. There were no fragments identified or retrieved during the procedure. At this time it is unknown what caused the breakage to occur.
 
Event Description
It was reported that during a da vinci-assisted hysterectomy surgical procedure, a cable broke on the mega suturecut needle driver instrument inside the patient. The customer was unsure if any fragments had fallen into the patient. The customer ordered an x-ray for the patient. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the surgeon stated that no visible fragments were identified. There were no fragments retrieved from the patient. No additional procedure was required. The customer performed an axr (abdominal x-ray). The surgeon did not know what could have caused the cable break; the instrument was on its last use. The instrument was in use for approximately five minutes when the issue was identified. The surgeon was suturing when the instrument stopped working; no fragments were seen. The surgeon was not sure if the instrument was inspected prior to use. The instrument did not collide with other instruments or hard materials. The instrument was not removed prior to the breakage. Upon instrument removal, the wrist was straightened. To his knowledge, the staff did not notice any resistance upon removal of the instrument through the cannula or damage. There are no images or video recordings of the procedure available for isi review.
 
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Brand NameENDOWRIST
Type of DeviceMEGA SUTURECUT ND
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key13814428
MDR Text Key292509539
Report Number2955842-2022-10660
Device Sequence Number1
Product Code NAY
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 02/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471309-15
Device Catalogue Number471309
Device Lot NumberN13210719 0029
Was Device Available for Evaluation? No
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/18/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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