MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MEDIUM-LARGE CLIP APPLIER

Model Number 470327-12

Device Problem Difficult to Remove (1528)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the medium-large clip applier instrument and performed failure analysis.The medium-large clip applier instrument was analyzed and found to have a severely bent grip tip.A review of an image of the instrument provided by the customer was performed by an intuitive surgical, inc.(isi) cde.Per the cde, in the image, a fully closed clip can be seen around tissue which has been released from the top jaw of the clip applier but is still attached to the bottom jaw.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, a medium-large clip applier would not release the attached clip from one side of the instrument's jaws.The surgeon was clipping the cystic duct and his normal practice is to clip on the gallbladder side along with the cystic duct side and then cut between to release the gallbladder.In this case, because the medium-large clip applier instrument would not release, the surgeon had to cut the cystic duct in order to safely remove the instrument.As a result, there was uncontrolled, spilling of bile into to the abdomen.The bile was suctioned but the event caused an increased risk of postoperative infection along with increased wound class.There was no significant bleeding due to the event.The patient is recovering well with no reports of postoperative complications.

• Brand Name: ENDOWRIST
• Type of Device: MEDIUM-LARGE CLIP APPLIER
• 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: 19076243
• MDR Text Key: 339775966
• Report Number: 2955842-2024-13092
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112465
• UDI-Public: (01)00886874112465(11)230405(10)K10230405(91)0003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/15/2024

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: 470327-12
• Device Catalogue Number: 470327
• Device Lot Number: K10230405 0134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• 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