MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; FENESTRATED BIPOLAR FORCEPS

Model Number 478093-03

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the tip of the fenestrated bipolar forceps (fbf) was broken and could not be pulled out from the trocar.The surgeon pulled the fbf instrument out while it was stuck in the trocar.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the fbf instrument was inspected prior to use with no issue.There was no fragment falling inside the patient¿s anatomy.The surgeon did not perform port incision enlargement.There was no patient¿s injury.The broken piece will be returned with the fbf instrument.

Manufacturer Narrative

Based on the claim against the product by the customer noting that the tip of the fenestrated bipolar forceps (fbf) instrument was broken, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The fbf instrument was analyzed and found to have a broken distal clevis.The broken pieces were returned, measuring roughly 0.170¿ x 0.297¿ and 0.170¿ x 0.311¿ in sizes.The grip tips were detached from the distal end due to the broken distal clevis.The fbf instrument was found to have the heat shrink torn at the distal clevis.There was no material missing.The fbf instrument was found to have a broken conductor wire at the distal end.No signs of thermal damage or damage to the conductor wire insulation were observed.The instrument was found to have a broken push rod at the distal end.The complaint regarding the broken tip of the fbf instrument was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.The root cause of a broken/cracked distal clevis is attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.Instrument collisions with other hand-held instrumentation or instrument driven outside the field of view can also cause damage to the instrument distal clevis.

Manufacturer Narrative

Additional failure analysis was performed on the fenestrated bipolar forceps instrument by an advanced failure analysis engineer.Initial findings were confirmed.The instrument was found to have a broken distal clevis.The distal clevis pieces were matched up to their break and aligned, indicating no missing pieces from the distal clevis.The instrument was additionally found to have a broken conductor wire.The broken distal clevis was lined up, and it showed that one conductor wire aligned to a break inside the distal clevis.The other conductor wire had a piece of the wire sticking out.It is likely that this conductor wire got pulled out before breaking.There is no missing piece of conductor wire.The instrument was additionally found to have a broken push rod at the distal end.Upon closer examination, there appeared to be a missing encap on the push rod assembly.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: SINGLE-SITE
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• 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: 17045818
• MDR Text Key: 317633105
• Report Number: 2955842-2023-15484
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874113738
• UDI-Public: (01)00886874113738(17)240531(10)L90220525
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K130726
• 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: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 478093-03
• Device Catalogue Number: 478093
• Device Lot Number: L90220525 0243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• Is the Device Single Use?: Yes
• 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