MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for ENDOWRIST INSTRUMENTS 470183-14 470183 manufactured by Intuitive Surgical, Inc.
[184991543]
(b)(4). Intuitive surgical, inc. (isi) received the permanent cautery hook instrument and performed a device evaluation. Failure analysis confirmed/replicated the initial complaint that the permanent cautery hook was stuck in a bent position. The instrument¿? S yaw pulley was found to be stuck due to charring/localized melting (thermal damage), which prevented movement of the instrument's distal end. Additionally, the instrument was found to have failed the electrical continuity test. The conductor wire cap was removed and the conductor wire weld location was found to have incurred thermal damage, which was also found on the yaw pulley (as noted above) and the conductor wire cap. Furthermore, the conductor wire¿? S insulation was found to have been damaged near the weld location. This complaint is being reported because damage to the weld or conductor wire within the instrument 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 likely cause or contribute to an adverse event if it were to recur. The following was found during the device evaluation, but is not related to the reportable finding: the instrument was found to have a derailed yaw cable at the distal end, which may also contribute to non-intuitive yaw motion. Device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system. This reported issue occurred on the instrument's first usage and, therefore, had not expired. Date of implant is blank because the product is not implantable. This report has been generated in response to fda inspectional observations dated 06-mar-2020.
Patient Sequence No: 1, Text Type: N, H10
[184991544]
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, a permanent cautery hook instrument was stuck in a bent position. The surgeon was unable to articulate the permanent cautery hook instrument, but was able to remove it without issues. The procedure was completed with a backup instrument after a delay of less than 15 minutes and there was no reported patient harm, injury, or adverse outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2020-10232 |
| MDR Report Key | 9881226 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-10-04 |
| Date Mfgr Received | 2019-10-18 |
| Device Manufacturer Date | 2019-08-15 |
| 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 | 3 |
| 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 | 2019-10-14 |
| Model Number | 470183-14 |
| Catalog Number | 470183 |
| Lot Number | N11190819 0103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 |