MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-01 for ATEC INTRODUCER LOCALIZATION SET SURESIGHT 0914-20-OB ILS 0914-20-OB manufactured by Hologic, Inc.
[49393337]
The device was received and visually inspected. The investigator verified that the obturator is broken. The distal tip of the obturator was not returned. The reported observation was confirmed. This observation is being trended and monitored. Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications. Currently unable to establish a relationship or impact to the reported observation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[49393338]
It was reported during a breast biopsy procedure (exact date unknown) the obturator tip fell off into the patient's breast. The procedure was completed with a second device. It is unknown if intervention was required. We have been unable to obtain additional information surrounding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00170 |
| MDR Report Key | 5764592 |
| Date Received | 2016-07-01 |
| Date of Report | 2016-06-03 |
| Date Mfgr Received | 2016-06-03 |
| Device Manufacturer Date | 2016-02-05 |
| Date Added to Maude | 2016-07-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ATEC INTRODUCER LOCALIZATION SET SURESIGHT |
| Generic Name | SURGICAL NEEDLE GUIDE |
| Product Code | GDF |
| Date Received | 2016-07-01 |
| Returned To Mfg | 2016-06-27 |
| Model Number | 0914-20-OB |
| Catalog Number | ILS 0914-20-OB |
| Lot Number | 602503 |
| Device Expiration Date | 2016-07-19 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-01 |