MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-05-03 for VARADY PHLEBECTOMY EXTRACTOR,6-3/4,SM HOOK/SPATULA 10310 manufactured by Integra York, Pa Inc..
[107983077]
The device was not returned to the manufacturer for physical evaluation. However, a picture was provided showing the phlebectomy extractor with a broken hook tip. Upon inspection of the picture the hook was missing from the tip. The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident. No service history was available to be reviewed. This complaint has been confirmed as damaged or worn. The root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[107983078]
The integra sales representative reported on behalf of the customer that on (b)(6) 2018 a 10310 varady phlebectomy extractor, 6-3/4, sm hook/spatula was broken at the tip of the hook. No patient contact, injury, or surgery delay was reported. Additional information was requested but no other clinical information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00065 |
| MDR Report Key | 7484159 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-05-03 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-05-09 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-05-03 |
| 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 | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARADY PHLEBECTOMY EXTRACTOR,6-3/4,SM HOOK/SPATULA |
| Generic Name | JARIT |
| Product Code | GAI |
| Date Received | 2018-05-03 |
| Returned To Mfg | 2018-05-08 |
| Catalog Number | 10310 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-03 |