MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD BLACK

Model Number 48345T-01

Device Problems Break (1069); Retraction Problem (1536)

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

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the curved-tip stapler sureform reload 45, instrument involved with this complaint and completed the device evaluation.Failure analysis found the primary failure of exposed component to be related to the customer reported complaint.The reload was found to have the knife exposed within the knife track.The reload was partially fired based on in-house testing and was found to have a firing failure.A piece, measuring 0.281" x 0.044", was found missing at the distal part of the reload.

Event Description

It was reported that during a da vinci-assisted surgical procedure, a blade was exposed on the stapler reload after firing.The procedure was completed with no reported injury.

• Brand Name: SUREFORM
• Type of Device: SUREFORM 45 RELOAD BLACK
• 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: 16927421
• MDR Text Key: 315275213
• Report Number: 2955842-2023-13390
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)N/A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48345T-01
• Device Catalogue Number: 48345T
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2019
• 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 Age: 23 YR
• Patient Sex: Female
• Patient Weight: 73 KG