MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for DYNJ47688C manufactured by Medline Industries Inc..
[135743340]
It was reported that as the gauze component was being removed from the surgical site, during a robotic gastrojejunostomy procedure, it ripped and a piece fell back into the surgical site. The gauze was being removed through a trocar at the time of the incident. When it was identified that the ripped piece fell back into the surgical site, it was removed through the trocar. The patient was under general anesthesia at the time of this incident. The procedure did not last longer than expected and the patient did not require additional anesthesia. There was no reported impact or adverse effect to the patient, the patient's stability, or the patient's plan of care. The reporting facility indicated that no sample was available to be returned to the manufacturer for evaluation. A root cause for the reported incident could not be determined. Due to the need for medical intervention to remove the ripped gauze piece from the surgical site, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[135743341]
It was reported that as the gauze component was being removed from the surgical site, during a robotic gastrojejunostomy procedure, it ripped and a piece fell back into the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2019-00001 |
| MDR Report Key | 8317514 |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-07 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-02-06 |
| Date Added to Maude | 2019-02-07 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | GAUZE IN DBD-ROBOTIC PACK |
| Product Code | FDE |
| Date Received | 2019-02-07 |
| Catalog Number | DYNJ47688C |
| Lot Number | 18LKC867 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-07 |