MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PROGRASP FORCEPS

Model Number 471093-11

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/20/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted malignant hysterectomy procedure, a piece of metal on the distal end of the prograsp forceps instrument's roller hooked an unspecified intra-abdominal structure, causing a possible unspecified injury to the small intestine.The small intestine was reportedly examined.The procedure was completed with a replacement prograsp forceps instrument.Intuitive surgical, inc.(isi) contacted the site for additional information; however, at the time of this report, no further details have been provided.

Manufacturer Narrative

Based on the current information provided, the cause of the intraoperative complication cannot be determined.The product has not been returned to intuitive surgical, inc.For evaluation.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.

• Brand Name: ENDOWRIST
• Type of Device: PROGRASP 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: 18187611
• MDR Text Key: 328739490
• Report Number: 2955842-2023-20521
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119785
• UDI-Public: (01)00886874119785(10)K10220919
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/26/2023

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: 471093-11
• Device Catalogue Number: 471093
• Device Lot Number: K10220919 0420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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: Female