MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-08 for ATEC INTRODUCER LOCALIZATION SET SURESIGHT 0914-20-OB ILS 0914-20-OB manufactured by Hologic, Inc.
[48057302]
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. If the device is returned and evaluation completed, a supplemental medwatch will be filed. 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
[48057303]
It was reported during a breast biopsy procedure on (b)(6) 2016, the obturator "tip broke off" inside the sheath prior to inserting into the patient. The procedure was completed with a second device. "no report of patient injury".
Patient Sequence No: 1, Text Type: D, B5
[51527724]
The returned device was received and visually inspected. The investigator verified that the distal tip of the obturator is broken. Cause is presently unknown for failure. The reported observation was confirmed. This observation is being trended and monitored.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2016-00142 |
| MDR Report Key | 5706553 |
| Date Received | 2016-06-08 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-05-10 |
| Date Mfgr Received | 2016-06-23 |
| Device Manufacturer Date | 2016-04-28 |
| Date Added to Maude | 2016-06-08 |
| 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 | 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 | 3 |
| Brand Name | ATEC INTRODUCER LOCALIZATION SET SURESIGHT |
| Generic Name | SURGICAL NEEDLE GUIDE |
| Product Code | GDF |
| Date Received | 2016-06-08 |
| Returned To Mfg | 2016-06-23 |
| Model Number | 0914-20-OB |
| Catalog Number | ILS 0914-20-OB |
| Lot Number | 604558 |
| Device Expiration Date | 2016-10-08 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-06-08 |