MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for ER320 manufactured by Sterilmed, Inc..
[126085106]
The patient was having gallbladder removed and surgeon placed several clips on the duct and artery. Surgeon noticed that some of the clips did not close properly, so he had to remove and replace the clips from a new applicator. Surgeon finished the case and was checking inside the patient when he noticed the j-hook tip in the belly. It had come off the megadine shaft inside the patient. Surgeon removed the tip from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8037140 |
| MDR Report Key | 8037140 |
| Date Received | 2018-11-05 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-04-13 |
| Report Date | 2018-11-01 |
| Date Reported to FDA | 2018-11-01 |
| Date Reported to Mfgr | 2018-11-05 |
| Date Added to Maude | 2018-11-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2018-11-05 |
| Model Number | ER320 |
| Catalog Number | ER320 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PKWY N STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-05 |