MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-01 for LEICA BIOSYSTEMS 39LC-500-9-L manufactured by Leica Biosystems Richmond.
[134866488]
Complaint data was reviewed from january 1st, 2017 to january 29th, 2019 and no other complaints were identified for this product lot that reported an issue with the product opening in processing. Five total products and eleven total lots were originally reported by the customer. Additional information was requested from the customer on the one product and lot that had irretrievable tissue loss. Product code 39lc-500-9-l, lot v20180721 was confirmed to have had irretrievable tissue loss by the customer. The product lot reported was not available in inventory for review by leica biosystems qa histotechs. Upon review with the sales team in contact with the customer, it was reported that the customer uses the same cassette multiple times. The product is labelled as a single use product only and the ifu states that the product lids should be discarded after one-time use. The customer used the product outside of intended use. No further investigation is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[134866489]
The customer was processing two tissue biopsies with the product, code 39lc-500-9-l, and two tissue biopsies were lost. One biopsy, a skin inclusion approximately 1 cm in size, was divided into two blocks and was diagnosed using the second block. The second was a single biopsy of a bone marrow tissue sample and the patient had been recalled to re-make the biopsy. The incident was reported to leica biosystems on (b)(6) 2018. The complaint record was created (b)(6) 2018 stating that a risk of tissue loss was present. Additional information on potential loss of tissue was requested (b)(6) 2018. Confirmation of tissue loss was not provided to the complaint handling team until 21january, 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419341-2019-00001 |
| MDR Report Key | 8299413 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-01 |
| Date of Report | 2019-02-01 |
| Date of Event | 2018-11-29 |
| Date Added to Maude | 2019-02-01 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 | LEICABIOSYSTEMS 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 | 3 |
| Brand Name | LEICA BIOSYSTEMS |
| Generic Name | ACTIVFLO ROUTINE I-TAPED-YELLOW 1000 |
| Product Code | IDZ |
| Date Received | 2019-02-01 |
| Model Number | 39LC-500-9-L |
| Lot Number | V20180721 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-02-01 |