MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-01 for CHAMPION SUTURE PASSER NEEDLE 3910-900-091 manufactured by Coorstek Medical.
[145769662]
Review of the device history record shows there were no non-conformance associated with this manufacture lot. The sample needles tested in this lot showed with 95% confidence that 99% of the manufacture lot would meet or exceed the minimum 24 cycle requirement. Since the product was not returned for evaluation, an exact root cause could not be determined. The alleged problem indicates repeated use, so it is possible the needles were used in a manner inconsistent with the instructions for use. Country of event: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[145769663]
Mr (b)(6) from the hospital reported to the ansm: "after each end of intervention, check the integrity of the champion needle in the clamp. Needle that was no longer intact because it was broken on 3. 4 mm. Piece not found. Clinical consequences noted: need to inform the patient who will be anxious. A priori no clinical consequences to be expected apart from a rather rare migration. Defective needle quarantined for expertise. Radio on (b)(6) 2019 with observation of the tip of the needle in a trans tendonous situation".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004086872-2019-00001 |
| MDR Report Key | 8471537 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-01 |
| Date of Report | 2019-06-06 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-03-26 |
| Device Manufacturer Date | 2017-06-06 |
| Date Added to Maude | 2019-04-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TRAVIS CANNEFAX |
| Manufacturer Street | 867 W 400 N |
| Manufacturer City | LOGAN UT 84321 |
| Manufacturer Country | US |
| Manufacturer Postal | 84321 |
| Manufacturer Phone | 4357744459 |
| Manufacturer G1 | COORSTEK MEDICAL |
| Manufacturer Street | 867 WEST 400 NORTH |
| Manufacturer City | LOGAN 84321 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84321 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAMPION SUTURE PASSER NEEDLE |
| Generic Name | SUTURE PASSER NEEDLE |
| Product Code | GAB |
| Date Received | 2019-04-01 |
| Model Number | 3910-900-091 |
| Catalog Number | 3910-900-091 |
| Lot Number | 1304213 |
| Device Expiration Date | 2019-06-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COORSTEK MEDICAL |
| Manufacturer Address | 867 W 400 N LOGAN UT 84321 US 84321 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-01 |