MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-02-15 for DAVINCI XI 380677-06 manufactured by Intuitive Surgical, Inc.
[139315499]
Intuitive surgical, inc. (isi) received the master tool manipulator (mtm) involved with this complaint and completed the device evaluation. During failure analysis, the reported error fault was reproduced during mtm calibration. Inspection indicated that the bottom of the axis 4 gear clamp had dropped below the mid-point of the housing boss, damaging the flat flex cables (ffc). The mtm was repaired by replacing the black and white ffc's and the screw in the gear clamp. Following this, the mtm was subjected to further testing and was restored to specification. Based on the information provided at this time, this complaint is being classified as a non-reportable event. Refer to decision tree reportability rationale. At this time, complaint investigation has been completed and this record will be closed. If additional information related to this complaint is obtained, the record will be reopened for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
[139315500]
It was reported that during a da vinci-assisted cardiac procedure, the system displayed non-recoverable error code 25521 and recoverable error code 23008. The user stated that the universal side manipulator (usm) arm movement became inactive and one of the usm arm installed with an instrument was stuck at the heart area during the event. The customer received phone assistance from the technical support engineer (tse). Review of the system logs confirmed the occurrence of the error faults on the right master tool manipulator (mtm). The user was advised to troubleshoot by power cycling the system and attempting to recover the error faults; however, the issue persisted. Following this, the surgeon made the decision to use another surgeon console to continue with the da vinci-assisted cardiac procedure. The procedure was completed with no further issue reported. No known impact or patient consequence was reported. Additional review of the system log identified that a large needle driver instrument was installed into one of the usm arms at the time of the event. An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The reported error fault was reproduced. The fse replaced the right mtm to resolve the issue. After replacement, the system was tested, operated as expected with no error fault and verified as ready for use. It was further reported that post operatively, the patient was administered "myocardial protection agent" as routine treatment for a da vinci surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2019-10114 |
| MDR Report Key | 8346084 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2019-02-15 |
| Date of Report | 2019-01-22 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2016-03-09 |
| Date Added to Maude | 2019-02-15 |
| 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 | PAT FLANAGAN |
| Manufacturer Street | 950 KIFER RD. |
| Manufacturer City | SUNNYVALE CA 94086 |
| Manufacturer Country | US |
| Manufacturer Postal | 94086 |
| Manufacturer Phone | 4085232100 |
| Manufacturer G1 | INTUITIVE SURGICAL, INC |
| Manufacturer Street | 950 KIFER RD. |
| Manufacturer City | SUNNYVALE CA 94086 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94086 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAVINCI XI |
| Generic Name | SURGEON SIDE CONSOLE, SMART PEDALS |
| Product Code | NAY |
| Date Received | 2019-02-15 |
| Returned To Mfg | 2019-01-28 |
| Model Number | 380677-06 |
| 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 | 950 KIFER RD. SUNNYVALE CA 94086 US 94086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-15 |