MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-20 for LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED manufactured by .
[81053009]
The trocar was examined and heavy contaminants were found throughout the device. The device was able to pass its pressure testing and would not be shipped to the customer in its current condition. While the root cause for the damage is unknown, it may be related to the extensive use of the device in the field.
Patient Sequence No: 1, Text Type: N, H10
[81053010]
It was reported that a black circular part broke off of the device during the procedure. Additional information has been requested but additional information was not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2017-00060 |
| MDR Report Key | 6727906 |
| Date Received | 2017-07-20 |
| Date Added to Maude | 2017-07-20 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2017-07-20 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-20 |