MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MONOPOLAR CURVED SCISSORS

Model Number 420179-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) instrument (pn: 420179-23 || ln: n10200713 764) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed nor replicated.The instrument passed recognition, functional, and electrical continuity and energy delivery tests.The instrument was fully functional.The instrument was found to have discoloration to its blade tips.No product issue was identified.If additional information is received, a follow-up mdr will be submitted.Site history review was conducted on 22-oct-2020 and showed additional complaints related to this event: prs 264738, and 262078.No image, or video clip for the reported event was submitted for review.System error log review was conducted on 24-oct-2020 for a procedure on (b)(6) 2020, on system sh1284.Three were no observed events in the system logs that would suggest a product issue and logged events were in line with normal system functionality.A review of the instrument logs was also performed.The alleged suspect mcs instrument pn: 420179-23 || ln: n10200713 764 || sn: (b)(4) was used in the procedure on (b)(6) 2020, and had 5 of 10 uses remaining; it was also used in a subsequent procedure on (b)(6) 2020 with 4 of 10 uses remaining.All reusable instruments used in the case were used in subsequent procedures with exception of the following: fenestrated bipolar forceps instrument ¿ pn: 420205-15 || ln: n10181219-546 || sn: (b)(4).A site review showed no record of a complaint filed against this instrument.Based on the information provided at this time, this complaint is reportable due to the following: it was reported that after completion of a da vinci-assisted total hysterectomy procedure on (b)(6) 2020, the patient developed symptoms on post-operative day 20 and went to the emergency room (er) on (b)(6) 220.The patient was admitted to the hospital and an exploratory laparotomy surgery was performed.An abscess was observed in the lower pelvis.¿the wound was left open until (b)(6) 2020¿ and a third surgery was performed to ¿close the wound¿.Although the surgeon claimed that the pelvic abscess was possibly caused by thermal spread of a monopolar curved scissors (mcs) instrument, the root cause of the post-operative complication is unknown.The product is not implantable.

Event Description

It was initially reported that a patient was brought back to surgery on (b)(6) 2020 for an exploratory laparotomy surgery.The primary surgeon thinks the patient experienced a possible thermal injury from the initial robotic hysterectomy.The monopolar curved scissors (mcs) used during the initial procedure was removed from circulation and sent to isi for analysis.On 22-oct-2020, isi obtained the following additional information regarding the reported event: a da vinci-assisted total hysterectomy was performed on (b)(6) 2020.The procedure completed without incident, no system issues, no instrument issues, and no reported patient injury.A grounding pad was in use on the patient¿s right side.A covidian force triad generator was in use and the settings were stated as being ¿set really low; probably like 40 across the board¿.There were no observed sparks or arcing reported during the procedure and no reported marks on the patient at/near the grounding pad or around any of the ports.A couple of weeks after the completed da vinci-assisted procedure, the patient went to the emergency room (er) in the middle of the night on (b)(6) 2020, and they were buckled over in pain.The patient was admitted to the hospital and a trauma surgeon performed an exploratory laparotomy surgery.An abscess was observed in the lower pelvis.No additional clinical detail was known other than ¿the wound was left open until (b)(6) 2020.¿ a third surgery was performed to ¿close the wound.¿ the surgeon who performed the primary procedure was not present for the second surgery where the lower pelvis abscess was observed.However, she was able to join during the third surgery to close the wound.The surgeon feels that the abscess was caused by a thermal injury to the bowel during the initial procedure.Intuitive surgical, inc.(isi) had reached out to the customer to obtain additional information but has not yet received a response.All follow-up attempts have been exhausted.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: MONOPOLAR CURVED SCISSORS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10840942
• MDR Text Key: 216394864
• Report Number: 2955842-2020-11198
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111505
• UDI-Public: (01)00886874111505(10)N10200713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 420179-23
• Device Catalogue Number: 420179
• Device Lot Number: N10200713 764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention