MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; BOWEL GRASPER

Model Number 420177-07

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

Patient Problem Injury (2348)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the bowel grasper instrument (pn: 420177-07 || ln: t10200513 113 || sn: (b)(4)) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not reproduced and could not verify the external event.The instrument was placed and driven on an in-house system and passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.No grasping issues were observed.No sharp edges were observed on the grips tip.Additional finding not reported by site: the instrument was found to have a bent grip, causing side to side misalignment of the grips.There was a 0.028¿ offset at the tips.Root cause of this failure may be high force.Site history review was conducted and did not show any additional complaints related to this event.No image or video clip for the reported event was submitted for review.System error log review was conducted and found that there were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.A review of the instrument logs was performed.While all other reusable instruments (other than the bowel grasper instruments) used in the case have not been used in subsequent procedures at this time, a site history search shows no complaints filed against the instruments.There were three bowel grasper instruments recorded as in use during this procedure; two of which have the same base lot number.Failure analysis (fa) confirmed that the suspect instrument received was: bowel grasper pn: 420177-07 || ln: t10200513-113 which was in use 05:09 and had 11 of 20 uses remaining.Based on the information provided at this time, this complaint is reportable due to the following: during a da vinci-assisted revisional gastric bypass procedure, the patient allegedly sustained a bowel injury while the surgeon was grasping and releasing the bowel with a bowel grasper instrument.The surgeon repaired the bowel intra-operatively with four vicryl sutures.A backup bowel grasper instrument was installed.The procedure completed with no customer reported injury.However, at this time, the root cause of the patient¿s intra-operative complication is unknown.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was initially reported that during a da vinci-assisted surgical procedure, as the surgeon grasped then released the patient¿s bowel with a bowel grasper instrument, the bowel ¿tore¿.The surgeon repaired the bowel with an undisclosed amount of sutures.A backup bowel grasper instrument was installed.The procedure completed with no customer reported injury.On 25-nov-2020, intuitive surgical, inc.(isi) obtained the following additional information from the console surgeon regarding the reported event: during a da vinci-assisted revisional gastric bypass procedure, the surgeon was, ¿running the bowel with two graspers¿ and the, ¿one in right hand tore the bowel¿.The surgeon immediately applied a backup bowel grasper instrument and applied four vicryl sutures to repair the bowel intra-operatively.There was no additional unexpected bleeding and no other intra-operative complications.The procedure completed robotically with the use of a backup bowel grasper instrument and no reported patient injury.There have been no reports of post-operative complications and the patient was reported as doing fine.The female patient had a bmi of 44 and prior bariatric surgery.The surgeon attributed the cause of the event as being due to the jaws of the bowel grasper instrument yet the surgeon also stated that the patient¿s bowel was ¿fragile¿.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: BOWEL GRASPER
• 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: 11021505
• MDR Text Key: 221857016
• Report Number: 2955842-2020-11358
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111482
• UDI-Public: (01)00886874111482(10)T10200513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 420177-07
• Device Catalogue Number: 420177
• Device Lot Number: T10200513
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2020
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Other