MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-24 for 24 EA ISI DA VINCI S 8MM OBTURATOR 420023 manufactured by Teleflex Medical.
[184805500]
(b)(4). The device history review for the product 24 ea isi da vinci s 8mm obturator lot #73h1800102 investigation did not show issues related to the complaint. The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[184805501]
It was reported that the patient was undergoing a robotic assisted laparoscopic total hysterectomy, bilateral salpingectomy, cystoscopy. The surgeon placed the camera port into the abdomen after the obturator was removed, it was noted that the tip of the trocar was missing. The team could not confirm the tip was present prior to incision or it had broken off in the abdomen. The camera was advanced, and the abdomen surveyed. The plastic tip was not visualized in the abdomen or on the field. A new obturator was obtained and confirmed to be intact prior to use. The procedure was able to be completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2020-00284 |
| MDR Report Key | 9873540 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2018-08-08 |
| Date Added to Maude | 2020-03-24 |
| 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 | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 24 EA ISI DA VINCI S 8MM OBTURATOR |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC |
| Product Code | GCJ |
| Date Received | 2020-03-24 |
| Catalog Number | 420023 |
| Lot Number | 73H1800102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | MORRISVILLE NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |