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

Model Number 471405-06

Device Problem Difficult to Remove (1528)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/16/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted umbilical hernia etep (ventral hernia) procedure, the jaws of the force bipolar instrument became stuck, closed on tissue.The instrument was inspected before use by the medical technical assistant for surgery, and everything reportedly seemed in order.At the time this event occurred, the surgeon was grasping fatty tissue, and the instrument was in strong grip mode.No system faults or errors were generated at the time, and everything was running smoothly.While it was initially reported that the instrument jaws would not open with the instrument release key (irk), the customer later confirmed that the jaws successfully opened with the use of the irk.However, the joint of the instrument broke off, and the staff found it difficult to remove the instrument from the cannula, because the opening of the jaws was too wide to exit through the trocar.When asked if there were any adverse effects to the grasped tissue, the customer stated that there was traction of the muscle wall around the trocar.No tissue was removed unexpectedly, and there was no report of bleeding.Per the site, there was no harm done to the patient.The procedure was completed, with a 15-30 minute delay.

Manufacturer Narrative

Based on the customer's claim against the product by the customer, an investigation is in progress to determine the cause of this reported event.Intuitive surgical, inc.(isi) has not received the product for evaluation.If additional information is obtained, a follow-up mdr will be submitted.Per a review of the site's system logs for the reported procedure date, no related system errors occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the force bipolar instrument associated with this complaint, and a failure analysis (fa) investigation was completed.Fa confirmed the customer reported complaint, with the primary failure of broken instrument grip-tips.The instrument was found to have a broken grip at the lower grip base.A piece approximately 0.064" x 0.144" was found to be broken off; this broken piece was not returned.The instrument was installed on the in-house system, where it passed recognition and engagement.The grips moved intuitively, however one of the lower parts of the grip-tips was broken, with a missing piece.When the instrument was removed from the system, the broken grip-tip got caught during the exit from the cannula tip.As a result, the instrument was hard to remove.The instrument release key (irk) was successfully used, with no issue.Commonly, broken instrument grip-tips are attributed to mishandling/misuse, such as excess force applied to the instrument jaws.This damage may be attributed to either device design or use conditions.Regarding the device design, fragments can result as retention of the metal injection molding (mim) to the overmold (om) is insufficient.Regarding use, damage to the force bipolar instrument can occur while performing ¿off-label¿ surgical applications, such as needle bending/driving and suture snapping, mishandling the instrument causing collisions, and misusing the instrument.Additionally, the instrument was found to have a bent grip, causing side-to-side misalignment of the grips.There was a.024¿ offset at the tips.Commonly, this is caused by mishandling/misuse; bent grips with an offset < 0.05¿ are attributed to damage during use, as moderate misalignment of grip tips can be due to grasping either hard tissue/objects or collisions with other instruments.Additional observation(s) not related to the customer reported complaint include: the instrument was found to have a frayed grip cable at the distal idler pulley.The frayed cable strands stuck out at the wrist.Common causes of this failure mode include a component failure.Cable breakage, whether partial or full, may be attributed to reduction in ultimate strength of the material, which may be the result of damage to the cable through external collisions during use or during reprocessing.The instrument was also found to have indentations on the edge of the distal idler pulleys.Common causes of this failure mode include mishandling/misuse.These indentations are attributed to damage during use, which may include an accidental drop of the product or collisions with other objects or hard surfaces.Finally, the instrument was found to have damage to the conductor wire¿s insulation.The conductor wire was found with no exposed internal wire.No thermal damage was observed, and there were no missing pieces of the insulation.The instrument passed the electrical continuity test.The probable root-cause of a conductor wire damaged insulation is attributed to mishandling/misuse.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 17172566
• MDR Text Key: 317629947
• Report Number: 2955842-2023-16470
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K10220404
• Combination Product (y/n): N
• Reporter Country Code: LU
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: K10220404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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 Age: 42 YR
• Patient Sex: Male
• Patient Weight: 118 KG