MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CAMERA, 0°

Model Number	430060
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted malignant hysterectomy procedure, the system displayed ¿error 430060.¿ the error displayed prior to the insertion of the endoscope and throughout the procedure.The endoscope was inspected prior to use and ¿looked normal.¿ the displayed screen flipped up and down randomly although the surgeon had not pushed the ¿camera above/below¿ button to cause this.The issue initially occurred when the surgeon was holding the camera by hand prior to docking.The endoscope view was 30 degrees down and it started to change from down to up by itself without pushing the button on the housing of the endoscope.The issue occurred again when the endoscope was installed on the system after docking while the surgeon was dissecting vessels around the uterus; the surgical field was suddenly out of view.This happened three to four times during the procedure.The endoscope stayed in the same position while installed on the usm (universal surgical manipulator), but the view would change upside down on its own.Troubleshooting was performed by uninstalling the endoscope and reinstalling quickly.It would then work correctly for a while before the loss of vision issue would recur.The surgeon alleges that the patient experienced more bleeding due to loss of view throughout the dissection and procedure.However, per the surgeon, no critical injury occurred to the patient.Bleeding was observed from unspecified tissue.The blood loss amount is unknown.No blood transfusions were administered.Per the surgeon, there were no intra-operative or post-operative complications.It is unknown whether hospitalization was prolonged due to intra-operative complications.The patient has not returned due to post-operative complications.
Additional Manufacturer Narrative
D15 - based on the current information provided, the cause of the operative complication cannot be determined.Intuitive surgical, inc.(isi) has not received the instrument involved with this event for failure analysis evaluation.A follow-up mdr will be submitted if additional information is obtained.A system log review was performed for this procedure: no relevant errors were observed during this procedure.No image or video clips for the reported event were submitted by the customer for review.This complaint is being reported due to the following conclusion: during a da vinci assisted malignant hysterectomy procedure, the system displayed ¿error 430060¿.The displayed screen flipped up and down randomly although the surgeon had not pushed the ¿camera above/below¿ button to cause this.The issue occurred again when the endoscope was installed on the system after docking while the surgeon was dissecting vessels around the uterus; the surgical field was suddenly out of view.The surgeon alleges that the patient experienced more bleeding due to loss of view throughout the dissection and procedure.The source and cause of the operative complication, and blood loss volume are unknown.In addition, it is unknown what medical intervention (if any) was rendered due to the bleeding although no blood transfusions were required.

• Brand Name: ENDOWRIST SP
• Common Device Name: CAMERA, 0°
• 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 Key: 15655223
• Report Number: 2955842-2022-14759
• Device Sequence Number: 14943815
• Product Code: NAY
• UDI-Device Identifier: 00886874114384
• UDI-Public: (01)00886874114384
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430060
• Device Catalogue Number: 430060
• Device Lot Number: 000097-0628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian