MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-24 for CLASSIC PLUS 36-2018 manufactured by Symmetry Surgical Inc.
[118405349]
A needle holder insert broke during a surgical procedure into several pieces. The breakage was not noticed until the instrument made it to central processing. An x-ray was conducted on the patient and determined that pieces of the insert were left in the patient. The facility determined they did not need to re-open the patient to retrieve the pieces at this time. The needle holder had been repaired by a third-party repair facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2018-00018 |
| MDR Report Key | 7815150 |
| Date Received | 2018-08-24 |
| Date of Report | 2018-08-24 |
| Date of Event | 2018-07-27 |
| Date Mfgr Received | 2018-07-27 |
| Date Added to Maude | 2018-08-24 |
| 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. VICTORIA ROGERS |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Manufacturer G1 | SYMMETRY SURGICAL INC |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CLASSIC PLUS |
| Generic Name | NEEDLE HOLDER |
| Product Code | HXK |
| Date Received | 2018-08-24 |
| Model Number | 36-2018 |
| Catalog Number | 36-2018 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-24 |