MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-27 for SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT C6370 manufactured by Conmed Corporation.
[103945793]
The device was reported as being discarded at the user facility and will not be returned for evaluation by the manufacturer. The manufacturing document from the device history record have been reviewed with special attention to the manufacturing and inspection of the device. The device released for distribution was found to have met all specifications prior to shipment. This is the only complaint for this lot number and failure mode within the past two years. (b)(4). Per the instructions for use, the user is advised: if the hook or needle bend during use, immediately discontinue use and discard. There is an increased risk of hook or needle breakage and unintentional patient injury may result. Avoid lateral stresses to the instrument or device function may be compromised. There is an increased risk of hook or needle breakage and unintentional patient injury may result. Do not use if parts are broken, cracked or worn, or device function may be compromised. There is an increased risk of hook or needle breakage and unintentional patient injury may result. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[103945794]
It was reported by the sales representative on behalf of the facility that during a surgical event on (b)(6) 2018 the c6370, spectrum ii suture hook, medium crescent, broke while inside the cannula. None of the device components fell into the surgical site and no medical intervention was required for the patient. The device was then thrown away after removal from the cannula. There was no delay or cancellation of the surgery. This report is raised on the basis of device malfunction with a potential for injury with occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2018-00044 |
| MDR Report Key | 7374806 |
| Date Received | 2018-03-27 |
| Date of Report | 2018-03-27 |
| Date of Event | 2018-03-08 |
| Date Mfgr Received | 2018-03-08 |
| Device Manufacturer Date | 2017-09-18 |
| Date Added to Maude | 2018-03-27 |
| 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. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT |
| Generic Name | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC |
| Product Code | LXG |
| Date Received | 2018-03-27 |
| Catalog Number | C6370 |
| Lot Number | 863196 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 11311 CONCEPT BLVD LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-27 |