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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI PATIENT SIDE CART, 4-ARM

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INTUITIVE SURGICAL, INC DAVINCI SI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380614-11
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  malfunction  
Manufacturer Narrative
An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The fse confirmed the reported failure and replaced the endoscopic camera manipulator (ecm). The system was tested and verified as ready for use. Isi has received the ecm involved with this complaint, but device evaluation has not been completed. A follow-up mdr will be submitted upon completion of the analysis. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or video clip for the reported event was available for review. A review of the site's system logs for the reported procedure date was conducted by the tse during system troubleshooting. Investigation revealed there were no related system errors to have occurred during the surgical procedure that were related to the reported complaint. This complaint is reportable due to the following: system unavailability after the start of a surgical procedure caused the procedure to be converted to a laparoscopic procedure and may lead to an injury due to the patient¿s inability to tolerate a conversion. While there was no harm or injury to the patient, and the procedure was completed successfully via laparoscopy, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the endoscopic camera manipulator (ecm) could not be moved along the insertion axis. An intuitive surgical, inc. (isi) technical support engineer (tse) was contacted for troubleshooting assistance. The tse checked the log but no suspected error was logged. The customer was able to temporarily resolve the issue by unjamming the drape on the ecm; however, the issue reoccurred. The customer performed a hard power cycle of the patient side cart (psc) but the issue persisted. The procedure was converted to laparoscopic surgery with no reported injury. Isi followed up with the initial reporter and obtained the following additional information: the procedure was completed under laparoscopic surgery. There was no patient harm or injury. The customer completed troubleshooting with technical support; however, the issue was not resolved. There was no issue noted during set up of the system. The system was inspected prior to use and no issues were noted during port placements. It was unknown if there were any outside influences that were impeding the movement of the system. The procedure was in progress for 3 hours when the issue occurred. The patient did not experience any other post-operative complications. No video recording of the procedure was available for review.
 
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Brand NameDAVINCI SI
Type of DevicePATIENT SIDE CART, 4-ARM
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
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12352233
MDR Text Key267627181
Report Number2955842-2021-10977
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110690
UDI-Public(01)00886874110690
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Biomedical Engineer
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380614-11
Device Catalogue Number380614
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2013
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: 08/23/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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