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

Model Number 470172-16

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.The maryland bipolar forceps instrument, with no visible damage on the conductor wire, failed the electrical continuity test during preliminary testing.Further testing of the instrument reproduced the failed electrical continuity.The instrument was disassembled, and the conductor wire was found broken on the proximal end at the waterfall pulleys.No thermal damage was identified.The conductor wire was pinched between the main tube and input roll gear during assembly.This condition, over time, will cause the wire to break with instrument articulation.This conductor wire damage is attributed to an issue with the assembly process.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No procedure video or image was submitted to isi for review.A review of the instrument log for the maryland bipolar forceps instrument lot# n12200309 / sequence 0189 associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2020 on system sk0906.There was no recorded use of the instrument on the reported event date of (b)(6) 2020.The instrument has 7 remaining usable lives with no subsequent use recorded.The maryland bipolar forceps instruments are multiple-use electrosurgical endoscopic instruments with a grasping tip to be used in conjunction with the da vinci system and an external electrosurgical unit (esu).The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).It was reported that during a da vinci-assisted gastrectomy procedure, the user observed that the maryland bipolar forceps instrument became "unusable." the user continued the procedure using the backup instrument with no further issue reported.The instrument & accessory user manual states: always have a backup instrument or accessory available to complete the surgical procedure in case of instrument failure.This complaint is a reportable malfunction event due to the following: evaluation by failure analysis confirmed that the conductor wire was found broken on the proximal end at the waterfall pulleys with no evidence of user mishandling or misuse reported.Damage to the conductor wire at this location could lead to unintended electrical discharge at a location other than intended.While there was no harm or injury to patient, the reported failure mode could cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.Device expiration date for section d4 was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.The instrument has 7 remaining usable lives, therefore, had not expired.Field implant date is blank because the product is not implantable.Information for the blank fields in initial reporter is not available.Field recall (if recall number is given) is not applicable.

Event Description

It was reported that during a da vinci-assisted gastrectomy procedure, the user observed that the maryland bipolar forceps instrument became "unusable." the complaint alleged that the instrument did not work, therefore there was no energy delivered.There was no risk of any adverse event related to unintended energy discharge to the patient.The instrument was removed and inspection found no visible damage on the conductor wire.Troubleshooting was attempted by replacing the instrument energy cable; however, the issue persisted.The user continued the procedure using the backup instrument with no further issue reported.No impact or patient consequence was reported.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 11214014
• MDR Text Key: 228169893
• Report Number: 2955842-2021-10072
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)N12200309
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/14/2021

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
• Device Operator: Health Professional
• Device Model Number: 470172-16
• Device Catalogue Number: 470172
• Device Lot Number: N12200309 0189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2020
• 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