MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-25 for ENDOWRIST INSTRUMENTS 470183-14 470183 manufactured by Intuitive Surgical, Inc.
[184983353]
Intuitive surgical, inc. (isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation. Failure analysis replicated/confirmed the reported issue and found the instrument to have a broken conductor wire at the yaw pulley, which resulted in a failed electrical continuity test. Thermal damage was identified on the wire-yaw pulley entry, the conductor wire weld, the conductor wire cap, the monopolar yaw pulley, the distal clevis, and the proximal clevis. Based on the information provided at this time, this complaint is being reported because the permanent cautery hook instrument arced, which was confirmed via isi's failure analysis investigation. Furthermore, damage to the weld or conductor wire within the instrument could lead to unintended electrical discharge at a location proximal to the intended location. While there was no harm or injury to patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur. The following were also found during this device's evaluation, but are not related to the reportable finding: the instrument was found to have the yaw cable frayed at the distal end. The instrument was found to have a dislodged flush tube, which is most commonly caused by user mishandling/misuse. The instrument also had various scratch marks with light material removed on the main tube. The scratch marks measured between 0. 025? And 0. 462? In length and are attributed to mishandling/misuse.
Patient Sequence No: 1, Text Type: N, H10
[184983354]
It was reported that during a da vinci-assisted prostatectomy surgical procedure, a permanent cautery hook instrument arced when energy was activated. The customer reported that the insulation appeared to be damaged. The procedure was completed with no reported patient harm, injury, or adverse outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2020-10233 |
| MDR Report Key | 9881217 |
| Report Source | OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2019-08-01 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID WANG |
| Manufacturer Street | 3410 CENTRAL EXPRESSWAY |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal | 95051 |
| Manufacturer Phone | 4085232100 |
| Manufacturer G1 | INTUITIVE SURGICAL, INC |
| Manufacturer Street | 3410 CENTRAL EXPRESSWAY |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOWRIST INSTRUMENTS |
| Generic Name | PERMANENT CAUTERY HOOK |
| Product Code | NAY |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-01-27 |
| Model Number | 470183-14 |
| Catalog Number | 470183 |
| Lot Number | N11190805 0189 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Manufacturer Address | 3410 CENTRAL EXPRESSWAY SANTA CLARA CA 95051 US 95051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |