MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-07 for MAJ-1632 MOUTHPIECE (BOX 50 PCS) K10020960 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[132341483]
The mouthpiece device has not returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. To prevent patient injury, the device instructions document cautions that the patient? S teeth be checked before device placement, and recommends that dentures or denture plates be removed. The instructions document also has directions for pre-procedure inspection of the device, including inspection for deformation and damage, and verification of expiration date. The instructions document also cautions that during the procedure the clinician should,? Monitor patient during use to ensure no injury is caused by the mouthpiece in the oral cavity.? Also during removal,? Care should be taken when removing mouthpiece to prevent injury in the oral cavity.? To avoid deterioration of the device during storage,? Store the device in a clean, dry, well ventilated room, maintained at ambient temperature. Do not store the mouthpiece in direct sunlight, at high temperature, in high humidity, or exposed to x-rays and/or ultraviolet-rays. Doing so could damage the mouthpiece.?
Patient Sequence No: 1, Text Type: N, H10
[132341484]
Olympus was informed that during an unknown endoscopic procedure, the mouthpiece device for the unknown model endoscope caused a cut on the outside of the patient? S lip. It was reported that the injury was related to the device dimension being too long down into the mouth. There was no excessive bleeding and no further patient intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00330 |
| MDR Report Key | 8224759 |
| Date Received | 2019-01-07 |
| Date of Report | 2019-06-14 |
| Date of Event | 2018-12-10 |
| Date Mfgr Received | 2019-05-17 |
| Date Added to Maude | 2019-01-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAJ-1632 MOUTHPIECE (BOX 50 PCS) |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2019-01-07 |
| Returned To Mfg | 2019-02-14 |
| Model Number | K10020960 |
| Lot Number | 20183750 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. |
| Manufacturer Address | KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA, ESSEX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-07 |