MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-02-28 for OLYMPUS INSTRUMENT CHANNEL ADAPTOR MAJ-1606 K10007072&K10016091 manufactured by Keymed (medical & Industrial Equipment), Ltd..
[3170623]
During a diagnostic colonoscopy, when the user inserted biopsy forceps (fb-210u) into the instrument channel adaptor (maj-1606) of an endoscope, the back seal part of the maj-1606 detached and dropped into the pt's body. The part was retrieved using unspecified forceps. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10529999]
The maj-1606 is a single use device which is supplied sterile. The device referenced in this report has been returned to olympus (b)(4) who have arranged sterilization of the device. Once sterilization is complete, the device will be returned to (b)(4) to complete the full investigation. (b)(4) have received photographs of the device referenced in this report and are working to replicate the fault on a maj-1606. To assist the investigation, (b)(4) have requested olympus (b)(4) to ask the health center questions relating to the identity of the lot number, the manipulation of the forceps, and the condition of the forceps after the event. There is no reported pt injury and this report is submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611174-2013-00001 |
| MDR Report Key | 2992921 |
| Report Source | 01,07 |
| Date Received | 2013-02-28 |
| Date of Report | 2013-02-28 |
| Date of Event | 2013-02-07 |
| Date Mfgr Received | 2013-02-07 |
| Date Added to Maude | 2013-05-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ALISON PRIOR, MANAGER |
| Manufacturer Street | STOCK RD. |
| Manufacturer City | SOUTHEND-ON-SEA, ESSEX SS2 5GH |
| Manufacturer Country | UK |
| Manufacturer Postal | SS2 5GH |
| Manufacturer Phone | 1702616333 |
| Manufacturer G1 | MEDICAL DEVICE MANUFACTURING CENTER |
| Manufacturer Street | 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 | 2013-02-28 |
| Model Number | MAJ-1606 |
| Catalog Number | K10007072&K10016091 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
| Manufacturer Address | UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-28 |