MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PK DISSECTING FORCEPS

Model Number	420227-11
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted total benign hysterectomy procedure, bipolar energy stopped working and the patient experienced a small amount of bleeding.The issue occurred when the customer ¿changed between the ft10 bipolar and the gyrus pk bipolar¿ instruments.The pk instrument had been in use and worked fine the entire procedure up to the point of the swapping instrument issue.The surgeon was working with the cervix wall to cut around and detach the cervix from vaginal wall to remove the uterus.The surgeon had cauterized with an unspecified instrument and went to continue cautery with the pk dissecting forceps (pk) instrument but cautery in ¿the pk didn¿t work¿ and a small amount of bleeding from an unspecified small vessel was observed.The surgeon quickly clamped the vessel to control the small amount of additional bleeding that was described as ¿little to no bleeding¿, ¿not enough to even measure or estimate¿ and no blood transfusion was required.The procedure was completed with use of a backup pk instrument with cautery functionality and with external foot pedals.There was no patient harm or injury.The patient is doing fine and there have been no reports of post-operative complications.
Additional Manufacturer Narrative
Based on the current information provided, the cause of the intra-operative complication is unknown.As requested, on 10-feb-2021 an isi field service engineer (fse) followed up with the customer via phone at the agreed time and they confirmed that there were no issues using the accessory generator that morning.A second follow-up was conducted on (b)(6) 2021 via the phone conversation between the fse and the customer, who confirmed that all equipment was operating as expected.The service request was closed as phone fix.If additional information is received, a follow-up mdr will be submitted.System error log review was conducted on 10-feb-2021 for a procedure on (b)(6) 2021 on system sh0186.While multiple system messages and errors were found in the logs, there were no observed events in the system logs noted as being specific to a pk instrument or that would suggest a product issue.A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.No image or video clip for the reported event was submitted for review.This event is being reported due to the following conclusion: during a da vinci-assisted total benign hysterectomy procedure, bipolar energy stopped working and the patient experienced a small amount of bleeding.The issue occurred when the customer ¿changed between the ft10 bipolar and the gyrus pk bipolar¿ instruments.The procedure was completed with use of a backup pk instrument.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PK DISSECTING FORCEPS
• 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: 14867880
• Report Number: 2955842-2022-12611
• Device Sequence Number: 14737282
• Product Code: NAY
• UDI-Device Identifier: 00886874111673
• UDI-Public: (01)00886874111673(10)N10191202
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K061260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2021

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: 420227-11
• Device Catalogue Number: 420227
• Device Lot Number: N10191202 493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2019
• 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 Sex: Female