MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-17 for ENDOCATCH 10 MM * manufactured by Covidien, Llc.
[5846421]
We have had several reported instances where, after the endocatch bag with the specimen in it has been removed from the retractable ring, the remaining piece of plastic bag on the ring has fallen off inside the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4855737 |
| MDR Report Key | 4855737 |
| Date Received | 2015-06-17 |
| Date of Report | 2015-06-17 |
| Date of Event | 2015-05-28 |
| Report Date | 2015-06-17 |
| Date Reported to FDA | 2015-06-17 |
| Date Reported to Mfgr | 2015-06-19 |
| Date Added to Maude | 2015-06-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOCATCH |
| Generic Name | LARYNGOSCOPE, ENDOSCOPE |
| Product Code | CAL |
| Date Received | 2015-06-17 |
| Model Number | 10 MM |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, LLC |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-17 |