MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-12 for GREENSMART BOVI PEN IN GOR PACK DYNJ46077A manufactured by Medline Industries Inc.
[45034985]
Patient Sequence No: 1, Text Type: N, H10
[45034986]
During ileostomy reversal procedure, physician noticed that the esu machine was making noise as if the surgical pencil was being used. In fact, the surgical pencil was not being used and was lying on the drapes. Nurse unplugged the surgical pencil from the machine and the noise stopped. The surgical pencil was plugged it back in to make sure it was the pencil that was faulty, and when plugged back in, the machine alarmed like the pencil was in use. Physician noticed that the blue coag button was stuck and that was why it was going off when not in use. This facility has had multiple similar issues with surgical pencils within the last week. The manufacturer has been notified and product is being returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5649733 |
| MDR Report Key | 5649733 |
| Date Received | 2016-05-12 |
| Date of Report | 2016-05-10 |
| Date of Event | 2016-04-26 |
| Report Date | 2016-05-10 |
| Date Reported to FDA | 2016-05-10 |
| Date Reported to Mfgr | 2016-05-10 |
| Date Added to Maude | 2016-05-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GREENSMART BOVI PEN IN GOR PACK |
| Generic Name | SURGICAL KIT |
| Product Code | LRP |
| Date Received | 2016-05-12 |
| Catalog Number | DYNJ46077A |
| Lot Number | 16CD1427 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN, IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-12 |