MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-12-04 for BERKELEY VACURETTE CANNULAS, CURVED 21853 manufactured by Gyrus Acmi L.p..
[18297772]
During a suction dnc the customer discovered the tip had broken off the device. They could not find the tip so they performed a hysteroscopy. No patient injury reported and customer did not say if they found the tip after performing the hysteroscopy. Customer said that they are not sure if it was broken before they used it or during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[18436346]
The vacurette was received with a 24mm crack running lengthwise down the tube originating from the open distal end. The distal end has been chipped, the fragments have not been returned. At this time we cannot determine with any certainty how the crack originated or what caused the distal end to chip away. A review of the complaint data base does not indicate trending for this failure mode, we will continue to monitor the complaint data base for any further occurrences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005975494-2013-00010 |
| MDR Report Key | 3599540 |
| Report Source | 06 |
| Date Received | 2013-12-04 |
| Date of Report | 2013-11-06 |
| Date of Event | 2013-11-06 |
| Date Mfgr Received | 2013-11-06 |
| Date Added to Maude | 2014-03-14 |
| 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 | MR TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI L.P. |
| Manufacturer Street | 6845 WEDGEWOOD RD. |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BERKELEY VACURETTE CANNULAS, CURVED |
| Generic Name | VACURETTE |
| Product Code | HHI |
| Date Received | 2013-12-04 |
| Returned To Mfg | 2013-11-27 |
| Model Number | 21853 |
| Catalog Number | 21853 |
| Lot Number | 05134143 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI L.P. |
| Manufacturer Address | 6845 WEDGEWOOD RD. MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-12-04 |