MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 45 RELOAD

Model Number	41445G-05
Medical Device Problem Codes	No Device Output (1435); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the green reload accessory involved with this complaint and completed the device evaluation.As the customer could not identify which part had an issue, failure analysis could not confirm nor refute the reported event.The green reload was visually examined, and no physical damage was observed.The reload had not be fired at all.No pushers of the staples were found at the bed surface the cartridge.The reload knife was still concealed at the proximal end of the cartridge.The reload cover was still secured on the body of the reload.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, a ¿restore motor pack to control box connection¿ error occurred several times.The customer exchanged out the sureform 45 stapler instrument and cable, but recognition errors (no icb blue led, turned on red led, etc.) occurred.The customer could not complete the given troubleshooting steps as it would take a long time to resolve the issue.The user could not use the reload to fire.The procedure was converted to laparoscopic surgery with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer suspected that there is a problem with the i&a (stapler instrument, reload) but was unsure exactly which part had an issue.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45 RELOAD
• 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: 17067493
• Report Number: 2955842-2023-15805
• Device Sequence Number: 6689023
• Product Code: GDW
• UDI-Device Identifier: 10886874112806
• UDI-Public: (01)10886874112806(10)DS1191906
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K113706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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
• Operator of Device: Health Professional
• Device Model Number: 41445G-05
• Device Catalogue Number: 41445G
• Device Lot Number: DS1191906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown