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

Model Number 471405-06

Device Problem Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the cause of the reported complication has been determined to be product related, however, the cause of the customer reported failure mode cannot be determined. The force bipolar instrument has not been returned to intuitive surgical, inc. (isi) for evaluation. If additional information is received, a follow-up mdr will be submitted. Logs confirmed that the force bipolar instruments have not been used in subsequent procedures. A review of instrument reports was performed and shows three force bipolar instruments were used in the component separation tar procedure. It is unknown which force bipolar instrument had the reported issue. Logs confirmed that the force bipolar instruments have not been used in subsequent procedures. The force bipolar (part # 471405-6; /lot # k10211018-0078) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2022 on system (b)(4). The alleged event occurred on the 1st use of the instrument. The force bipolar (part # 471405-6; / lot # k11210816-0156) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2022 on system (b)(4). The alleged event occurred on the 5th use of the instrument. The force bipolar (part # 471405-6; / lot # n11210621-0219) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2022 on system (b)(4). The alleged event occurred on the 11th use of the instrument. A review of the site's complaint history does not show any additional complaints related to this event no image or video clip for the reported event was submitted for review. This complaint is being reported due to the following conclusion: during a da vinci-assisted component separation surgical procedure, the wrist of the force bipolar was getting caught on tissue. The surgery continued robotically. No other information was provided. The cause of the customer reported failure mode is unknown.

Event Description

It was reported that during a da vinci-assisted component separation surgical procedure, the wrist of the force bipolar was getting caught on tissue. The surgery continued robotically. No other information was provided. Intuitive surgical, inc. (isi) has made multiple follow up attempts to obtain additional information concerning the reported event with no success.

• 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: 13865114
• MDR Text Key: 293103709
• Report Number: 2955842-2022-10721
• 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: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2022
• 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: 03/23/2022 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES