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

Model Number	470298-11
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler 45 instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed, but did not replicate the customer reported complaint.Fa reviewed the logs and noted the stapler instrument was found to have a firing failure; however, this was not replicated during testing.The instrument was placed and driven on an-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions, clamped, fired, and unclamped without any issues.
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass (gb) surgical procedure, the stapler 45 instrument fired a green reload accessory without any issue(s) during the first firing.On the second fire, with another green reload, only a staple line was formed without a cut.The surgeon attempted a third green reload, and only a stapler line was formed without a cut again.The customer used a second stapler 45 instrument, and the surgeon fired a green reload accessory without issue, during the first firing.On the second fire, with another green reload, the stapler instrument stopped halfway, with the message: "unable to complete fire.Tap blue pedal to unclamp then remove stapler.Warning: blade may be exposed." it was found that the staple line was halfway through, with an irregular staple line.The surgeon stopped the bleeding with robotic bipolar and harmonic instruments.The customer removed the second stapler instrument and used a third, backup stapler 45 instrument.The third stapler instrument worked fine for firing; however, when the customer attempted to remove the instrument, it was stuck to the sterile adapter (sa).The customer pressed the emergency stop button and used the stapler release kit (srk) to remove the instrument manually.The customer experienced a procedure delay of 30 minutes or more.The surgeon made the decision to undock the da vinci and convert to a traditional laparoscopic techniques, with no injury reported.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: for the first stapler instrument, the system did not generate any message; however, after the fire, it was found that the stapling was not completed properly, without a cut.For the second stapler instrument, "unable to complete fire.Tap blue pedal to unclamp then remove stapler.Warning: blade may be exposed" was displayed.For the third stapler instrument, there was no error message; but, the customer was not able to remove the stapler instrument from the sa.The bleeding reported was oozing from non-vascular stomach tissue with less the 400 ml of blood loss.No blood transfusion was administered.No materials obstructing the stapler instrument were encountered.No tissue bunching occurred and no buttress material was used.The reloads were discarded after the procedure.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45
• 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: 17038005
• Report Number: 2955842-2023-15299
• Device Sequence Number: 6515884
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)S11170208
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: 470298-11
• Device Catalogue Number: 470298
• Device Lot Number: S11170208 0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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