MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-11 for IP ACTIVFLO BIOPSY III, ORANGE TISSUE CASSETTES 39LC-625-7 manufactured by Leica Biosystems Richmond.
[113740988]
As per customer contact, one patient ((b)(6 )year old male) specimen (rectum polyp) in 1 leica activflo biopsy iii cassette was loaded on a vip processor on friday, (b)(6) 2018 to come off on monday, (b)(6) at 5:30 am. The lid of the cassette reportedly opened during processing and the specimen was lost. Total number of cassettes loaded in the run was 71. A sample of the cassettes was provided to the sales representative by the customer and was sent back to the manufacturer for evaluation. Additionally, product of the same lot reported was pulled from inventory for testing by qa histotechs to attempt to replicate customer complaint. All cassettes remained closed during processing. Upon the receipt of product returned by the customer, the product was sent to qa histotechs to attempt to replicate customer complaint. All cassettes remained closed. In opening the cassettes after processing, there was the expected amount of resistance in removing the lids. All cassettes were found to function as designed.
Patient Sequence No: 1, Text Type: N, H10
[113740989]
On monday, (b)(6), a sales representative of leica biosystems was notified of patient tissue lost by the customer due to the cassettes reportedly opening during processing. Patient must undergo another biopsy due to tissue loss.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419341-2018-00003 |
| MDR Report Key | 7679701 |
| Date Received | 2018-07-11 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-06-11 |
| Date Mfgr Received | 2018-06-11 |
| Date Added to Maude | 2018-07-11 |
| 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. PETER SPARACIO |
| Manufacturer Street | 5205 US HIGHWAY 12 |
| Manufacturer City | RICHMOND IL 60071 |
| Manufacturer Country | US |
| Manufacturer Postal | 60071 |
| Manufacturer Phone | 8156782000 |
| Manufacturer G1 | LEICA BIOSYSTEMS RICHMOND |
| Manufacturer Street | 5205 US HIGHWAY 12 |
| Manufacturer City | RICHMOND IL 60071 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IP ACTIVFLO BIOPSY III, ORANGE TISSUE CASSETTES |
| Generic Name | TISSUE CASSETTES |
| Product Code | IDZ |
| Date Received | 2018-07-11 |
| Model Number | 39LC-625-7 |
| Lot Number | 625-LID-7-171221-A Q14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS RICHMOND |
| Manufacturer Address | 5205 US HIGHWAY 12 RICHMOND IL 60071 US 60071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-11 |