MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-24 for SYMMETRY DIETHRICH 32-844 manufactured by Symmetry Surgical Inc.
[136010587]
The device in question was purchased (b)(6) 2017 and had approximately 1. 5 years of use. Upon receiving the returned device, the hardness and material of the device were evaluated. It was determined that the device was within specifications. Upon further evaluation of the device, it was noticed that the cutting edges were scratched and chipped in some place. This type of damage is consistent with damage that would occur if the scissor was used in a way not intended for the purpose of the device. This particular device has an extremely delicate scissor tip that can easily become broken if used incorrectly. This is the only complaint recorded for this device with (b)(4) sold. This report can be seen as the final report. If additional information is received that alleges any additional patient involvement or a need for corrective actions a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[136010588]
The tip of the diethrich scissor broke off. It was noticed that the tip was broken in reprocessing. As a result the patient had to be recalled and an investigation was carried out to determine if the piece remained in the patient. It was communicated that the patient was not impacted by the broken tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2019-00003 |
| MDR Report Key | 8274807 |
| Date Received | 2019-01-24 |
| Date of Report | 2019-01-24 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2019-01-07 |
| Date Added to Maude | 2019-01-24 |
| 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 | BRANDI MEATH |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| 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 | SYMMETRY DIETHRICH |
| Generic Name | SCISSORS |
| Product Code | LRW |
| Date Received | 2019-01-24 |
| Returned To Mfg | 2019-01-23 |
| Catalog Number | 32-844 |
| Lot Number | 110216 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-24 |