MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-08-22 for BIPOLAR LAPAROSCOPIC LOOP BL0533 manufactured by Gyrus Acmi Inc..
[21733822]
The user facility reported that the black insulated coating of the device cracked and a chip fell into the patient. The chip was retrieved from the patient. No patient injury was reported. Olympus followed up with the user facility via telephone to obtain more detailed information about the reported event but with no results.
Patient Sequence No: 1, Text Type: D, B5
[21916993]
The device referenced in this report has not yet been returned to olympus for evaluation. The exact cause of the reported event could not be conclusively determined. If additional information is received at a later time this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00333 |
| MDR Report Key | 4077575 |
| Report Source | 05,06 |
| Date Received | 2014-08-22 |
| Date of Report | 2014-07-31 |
| Date of Event | 2014-07-31 |
| Date Mfgr Received | 2014-07-31 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-09-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Manufacturer G1 | GYRUS ACMI |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772210 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01772 2104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIPOLAR LAPAROSCOPIC LOOP |
| Generic Name | BIPOLAR LAPAROSCOPIC LOOP |
| Product Code | HIN |
| Date Received | 2014-08-22 |
| Model Number | BL0533 |
| Catalog Number | BL0533 |
| Lot Number | U1310125 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI INC. |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772210 US 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-22 |