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

Model Number 471405-06

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

Based on the claim against the product by the customer noting that the force bipolar instrument could not be removed due to the tip was broken and stuck at the cannula, an investigation is in progress to determine the cause of this reported event.Intuitive surgical, inc.(isi) has requested the force bipolar instrument for evaluation, but the instrument has not yet been received as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned for analysis and/or if additional information is received.An image of the force bipolar instrument related to this event was received.A review of the submitted image was performed by an isi regulatory post market surveillance (rpms) analyst.The image confirmed that the instrument jaw was sticking out/dislodged at the proximal end.The root cause of the failure mode cannot be confirmed without the returned device.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the force bipolar instrument's wrist was broken, and the tip was stuck at the cannula.Therefore, the surgeon could not remove the instrument through the cannula.The surgeon had to use an instrument release kit (irk) in order to remove the instrument from the patient.The procedure was converted to laparoscopic surgery.Intuitive surgical, inc.(isi) performed follow-up with the customer and obtained the following additional information regarding the reported event: the force bipolar instrument was reportedly inspected prior to use, and no issue was noted.No obvious instrument collisions were observed during the procedure.The surgical staff tried to use an irk to rotate the instrument tip to remove the instrument from the cannula.In addition, the port incision was increased by the surgeon in an attempt to remove the instrument and cannula together as one piece.It was confirmed that no fragments fell inside the patient during the procedure.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The force bipolar instrument was analyzed and found to have a bent grip, causing vertical misalignment of the grips.There was a portion of the grip tips that extended further than manufactured.Failure analysis found the primary failure of the bent grips to be related to the customer reported complaint.In addition, isi performed follow-up and obtained the following additional information regarding the reported event: the instrument jaws were not stuck on tissue when the issue occurred.The surgeon elected to convert to laparoscopic surgery for safety reasons.

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: 17131267
• MDR Text Key: 317212397
• Report Number: 2955842-2023-16325
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K10230111
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

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: K10230111 0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2023
• 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: Female