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

Model Number	48645B-04
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The blue endowrist stapler 45 reload was an incidental return.No allegation was made against this product.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the procedure outcome field was selected in error.The procedure was completed robotically, but the customer used a laparoscopic instrument.The coordinator was not in the case.She was informed that during a sigmoid colectomy procedure, the surgeon had issues with two stapler 45 instruments.The first stapler fired successfully on colon tissue but would not unclamp from the tissue.The assistant had to use the stapler release key to open the jaws and removed the stapler.The customer does not know if the tissue was too thick or if there were any obstruction in the jaws of the stapler.Once the stapler was removed from the patient, the customer could not remove the reload from the stapler jaws.The second stapler 45 was used at this point, but this stapler failed to initialize, and they could not use it.The customer elected to use a third-party stapler for the rest of the case.The procedure was completed with no patient injury.The customer will rma both staplers.Information regarding patient demographics, relevant testing, and medical history was requested, however the coordinator was only able to report that the patient was a 50-year-old male that weighs 50 kilos.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the blue endowrist stapler 45 reload involved with this complaint and completed the device evaluation.The reload was returned with no reported complaint as a discrepant rma.The reload was found to have cartridge damage.Upon visual inspection, the reload appeared to be unused and unfired.The knife remains in the knife garage.No damage to the lead screw was observed.Root cause of this failure is attributed to mishandling/misuse.Additional finding not reported by site.The reload was found to have the cover missing and not returned with the reload.This reload was transferred to a failure analysis engineer (fae) for additional investigation.The reload came back with an instrument that had an unclamp failure, and logs show the user never used the stapler release key (srk) while the instrument was on the system but may have attempted to use it while the instrument was removed from the system.The fae confirmed that reload was unfired, and logs support that as well.The reload cartridge has damage adjacent to the tissue bump feature that suggests user may have tried to pry instrument jaws open while instrument was in a partially clamped state.The cover being missing is likely to have occurred after the instrument was removed from the system, as reload does not properly engage to channel without cover.The user likely attempted srk use while instrument was off the system and may have unclamped the jaws enough to be able to remove the reload.It is unclear why the cover was removed.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45 RELOAD BLUE
• 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: 17015526
• Report Number: 2955842-2023-14665
• Device Sequence Number: 12646962
• Product Code: GDW
• UDI-Device Identifier: 10886874112875
• UDI-Public: (01)10886874112875(10)L90200330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2021

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: 48645B-04
• Device Catalogue Number: 48645B
• Device Lot Number: L90200330 0032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2020
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 50 KG