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

Model Number 471405-06

Device Problem Mechanical Jam (2983)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/22/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted inguinal hernia repair, the force bipolar instrument failed to unclamp with master tool manipulator (mtm) activation or the use of the instrument release kit (irk) resulting in the peritoneal flap being entrapped.The peritoneal flap was being created in preparation for mesh.As a result, the surgeon cut out the tissue around the jaws of the force bipolar instrument and repaired the hole with suture.Additionally, the customer indicated that the instrument's wrist became dislodged at an unspecified time during the procedure.It is unclear if the wrist of the force bipolar instrument's wrist became dislodged before or after the instrument became stuck on tissue.A back-up force bipolar instrument was used and the procedure was completed robotically with no additional issues.

Manufacturer Narrative

Based on the current information provided, the cause of the customer reported failure mode of the wrist of the force bipolar instrument becoming dislodged and the jaws getting stuck on tissue cannot be determined.The product has not been returned to intuitive surgical, inc.(isi) for failure analysis evaluation.A review of the system logs has been conducted.There were no system errors found that would have caused or contributed to the reported event.This complaint has been reported due to the following conclusion: the force bipolar instrument failed to unclamp with mtm activation or the use of the irk resulting in the peritoneal flap being entrapped and subsequently cut out in order to retrieve the instrument.The hole created by the transection of the stuck tissue was repaired with sutures.Additionally, the instrument's wrist was reported to have been dislodged during the procedure.

Manufacturer Narrative

Intuitive has received the part associated with this complaint and completed investigations.Failure analysis (fa) investigations did not replicate nor confirmed the customer reported complaint of tissue entrapment.The instrument was placed and driven on an in-house system where it passed the recognition, grip, and engagement tests.The instrument moved intuitively with full range of motion in all directions and the tips opened and closed properly.The instrument was fully functional, and no product issue was identified.Issues related to instrument errors or complications using the instrument reported by the user with no underlying product issue may be related to mishandling/misuse and recognition issues.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Correction: annex d.

• 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: 16573593
• MDR Text Key: 311597053
• Report Number: 2955842-2023-11393
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K10220613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214095
• 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,Followup,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K10220613 0138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• 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 Sex: Male