MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-16 for SOVEREIGN ATRAUMATIC GRASPER, SINGLE ACTION, 5MM, 42CM PL049R manufactured by Synergy Health.
[53447615]
Device has not been returned to synergy health for evaluation. Complaint originator (orange coast medical) is holding device until their investigation is complete. Once returned, device will be sent to aesculap for evaluation. Risk manager ((b)(4)) for orange coast medical was contacted on (b)(4) 2016 to follow up in regards to the initial data received. He verbally confirmed all pieces were retrieved and no adverse event occurred and no patient injury involved.
Patient Sequence No: 1, Text Type: N, H10
[53447616]
Tip of the grasper broke off inside a patient. All pieces retrieved and accounted for. Event did not cause harm. Equipment failure without injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002028626-2016-00001 |
| MDR Report Key | 5880445 |
| Date Received | 2016-08-16 |
| Date of Report | 2016-08-15 |
| Date of Event | 2016-08-02 |
| Date Mfgr Received | 2016-08-02 |
| Device Manufacturer Date | 2016-07-29 |
| Date Added to Maude | 2016-08-16 |
| 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 | MR. JUSTIN MATCHETT |
| Manufacturer Street | 401 E JACKSON STREET SUITE 3100 |
| Manufacturer City | TAMPA FL 33602 |
| Manufacturer Country | US |
| Manufacturer Postal | 33602 |
| Manufacturer Phone | 562-428-58 |
| Manufacturer G1 | SYNERGY HEALTH |
| Manufacturer Street | 2240 E ARTESIA BLVD |
| Manufacturer City | LONG BEACH CA 90805 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90805 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SOVEREIGN ATRAUMATIC GRASPER, SINGLE ACTION, 5MM, 42CM |
| Generic Name | LAPAROSCOPY KIT |
| Product Code | FDE |
| Date Received | 2016-08-16 |
| Model Number | PL049R |
| Lot Number | 427202 |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGY HEALTH |
| Manufacturer Address | 2240 E ARTESIA BLVD LONG BEACH CA 90805 US 90805 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-16 |