MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST FORCE BIPOLAR

Model Number 471405

Device Problem Entrapment of Device (1212)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the cause of the customer reported failure mode and operative complication cannot be determined. The customer informed the isi csa that they plan to reprocess this force bipolar instrument to continue using it as they do not believe there is a malfunction of the product. A follow-up mdr will be submitted if additional information is obtained. A review of the system and instrument logs for this event has been performed and the following was observed: no relevant errors were observed during this procedure. This force bipolar instrument has not been reused in subsequent procedures. The customer has not created any product returns for this instrument. A video of this event was provided and reviewed by an isi post market surveillance specialist: the video is a total of eight seconds long and captures a video playing on a monitor. The video on the monitor shows the surgeon's view of the surgical field. The force bipolar instrument has tissue stuck in it's wrist. The force bipolar instrument is pulled away from the tissue, tearing most of the tissue. A strand of tissue is left stuck in the force bipolar wrist and a monopolar curved scissors (mcs) instrument is used to cut this strand. This complaint is being reported due to the following conclusion: during a da vinci-assisted inguinal hernia procedure, the wrist of the force bipolar instrument was catching peritoneal flap tissue. As a result, the surgeon excised the stuck tissue and sutured the tissue location. The cause of the customer reported failure mode and operative complication is unknown.

Event Description

It was reported that during a da vinci-assisted inguinal hernia procedure, the wrist of the force bipolar instrument was catching the peritoneal flap. The procedure was completed robotically. An intuitive surgical inc. (isi) clinical sales associate (csa) who was present during the procedure was contacted and additional information was obtained about the event: in this case, there was peritoneal tissue stuck in the wrist of the force bipolar instrument which required the surgeon to cut in order to remove the instrument. The excision site was sutured due to this event. There was no bleeding nor any negative impact to the patient. This resulted in a delay of 10 minutes. Isi contacted the surgeon of this procedure and additional information was obtained about the complaint: this event occurred while the surgeon was dissecting the inguinal hernia. The surgeon excised the stuck peritoneum tissue and then sutured the tissue location. No other intervention was performed due to this event. This event did not cause any bleeding. The surgeon reported this event impacted the procedure by adding more time to suture the location and it did not have any effect on the patient¿s health. The patient did not experience any post-operative issues and is doing well. The surgeon believes this event was caused by the force bipolar instrument as they said ¿the gears¿ on the wrist of the force bipolar instrument caught onto the tissue. The surgeon is unsure if this instrument is available for return.

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• 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: 14254925
• MDR Text Key: 290447918
• Report Number: 2955842-2022-11345
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 471405
• Device Catalogue Number: 471405
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Treatment Data

Date Received: 04/29/2022 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES