MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-03-15 for OLYMPUS INSTRUMENT CHANNEL ADAPTOR MAJ-1606 K10007072 manufactured by Keymed (medical & Industrial Equipment) Limited.
[15426006]
A piece of the valve included in the maj-1606 broke and was pushed by the biopsy forceps into the pt. The physician retrieved the part from the pt. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[15691946]
Add'l catalog #: k10016091. The maj-1606 is a single use device which is supplied sterile. The event took place in ( b)(6). This report is crossed referenced to mfr report # 9611174-2013-00001.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611174-2013-00002 |
| MDR Report Key | 3014585 |
| Report Source | 99 |
| Date Received | 2013-03-15 |
| Date of Report | 2013-03-15 |
| Date of Event | 2012-01-01 |
| Date Mfgr Received | 2013-02-21 |
| Date Added to Maude | 2013-05-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ALISON PRIOR, RA MANAGER |
| Manufacturer Street | STOCK RD. KEYMED HOUSE |
| Manufacturer City | SOUTHEND ON SEA, ESSEX SS2 5QH |
| Manufacturer Country | UK |
| Manufacturer Postal | SS2 5QH |
| Manufacturer G1 | MEDICAL DEVICE MANUFACTURING CENTER |
| Manufacturer Street | JOURNEYMAN'S WAY TEMPLE FARM INDUSTRIAL ESTATE |
| Manufacturer City | SOUTHEND ON SEA, ESSEX SS25TF |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SS2 5TF |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS INSTRUMENT CHANNEL ADAPTOR |
| Generic Name | MAJ-1606 INSTRUMENT CHANNEL ADAPTOR |
| Product Code | FEQ |
| Date Received | 2013-03-15 |
| Model Number | MAJ-1606 |
| Catalog Number | K10007072 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED |
| Manufacturer Address | UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-15 |