MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-05 for BIOPSY FCPS 5MM INS 32CM 615174 manufactured by Integra York, Pa Inc..
[141077659]
The device was not returned to the manufacturer for analysis. The lot number was not received to perform device history record review. A failure analysis and determination of root cause is not possible due to the lack of information received to perform a complete investigation. Product has not been returned. The reported complaint is unconfirmed. Device identifier: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141077660]
A sales specialist reported on behalf of a doctor, that three (3) of the biopsy fcps 5mm ins 32cm, product id 615174, was ordered for each of the lap bariatric sets. The doctor reported that? It is not addressing the liver biopsy at all and is causing excessive bleeding during his procedures?. Additional information was received on 25mar2019 reported that the device was in contact with the patient, however, there was no patient injury/death alleged. It was unknown if there was medical intervention required and if there was a surgical delay. The instruments were purchased in advance for a bariatric program and were not used until the 90-day period was over. The doctor reported that the three devices did not performed as he had expected. These devices tore tissue rather than a clean cut of the liver. Additional request for information has been sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00054 |
| MDR Report Key | 8488007 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-05 |
| Date of Report | 2019-03-18 |
| Date Mfgr Received | 2019-04-08 |
| Device Manufacturer Date | 2018-05-01 |
| Date Added to Maude | 2019-04-05 |
| 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 | BIOPSY FCPS 5MM INS 32CM |
| Generic Name | BIOPSY INSTRUMENTS |
| Product Code | KNF |
| Date Received | 2019-04-05 |
| Returned To Mfg | 2019-04-03 |
| Catalog Number | 615174 |
| 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 | 2019-04-05 |