MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-14 for IP ACTIVFLO BIOPSY III, LOOSE REF 39LC-625-7 manufactured by Leica Biosystems.
[111450111]
Patient had a screening colonoscopy done with finding of a sessile rectal polyp and hemorrhoids. Polypectomy done but during processing of the specimen, the specimen cassette opened in the processor, losing the polyp and no testing could be completed to determine the pathology of the specimen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077886 |
| MDR Report Key | 7605322 |
| Date Received | 2018-06-14 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-06-11 |
| Date Added to Maude | 2018-06-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IP ACTIVFLO BIOPSY III, LOOSE |
| Generic Name | BIOPSY CASSETTE, TISSUE |
| Product Code | IDZ |
| Date Received | 2018-06-14 |
| Returned To Mfg | 2018-06-11 |
| Model Number | REF 39LC-625-7 |
| Lot Number | 171221A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS |
| Manufacturer Address | RICHMOND |
| Brand Name | IP ACTIVFLO BIOPSY III, LOOSE |
| Generic Name | BIOPSY CASSETTE, TISSUE |
| Product Code | IDZ |
| Date Received | 2018-06-14 |
| Returned To Mfg | 2018-06-11 |
| Model Number | REF 39LC-625-9 |
| Lot Number | 170906A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS |
| Manufacturer Address | RICHMOND |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-14 |