MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for SINGLE USE SUCTION VALVE (STERILE) MAJ-209 manufactured by Olympus Medical Systems Corp..
[140153767]
The subject device was not returned. Therefore, the root cause was assumed based on the past similar cases. It was assumed that the breakage occurred at the proximal end of the suction connector. The manufacturing process and a molding supplier for the subject product were changed. After these changes, the complaints of the suction valve breakage has been raising. Omsc assumes that the cause of the damage to the product is that an unexpected large load was applied to the suction connector. Both "product before changes" and "product after changes" meet the product specification for durability. However, when an unexpected large load was applied to the suction connector, omsc confirmed that the product before changes does not break, but the product after changes may break. Omsc made the decision to re-produce the product which before changes. The instruction manual of the product has already warned as follows; attaching the suction valve to the endoscope press down on the suction valve's top surface with your both thumbs until it "clicks" into place. Inspection of operation: place the distal end of the insertion tube in sterile water and depress the suction valve. Confirm that water is continuously aspirated into the suction bottle of the suction pump. Removing the suction valve from the endoscope: rotate the suction connector clockwise with your thumb.
Patient Sequence No: 1, Text Type: N, H10
[140153768]
During an endoscopy, the subject device was used. The intended procedure was completed with the subject device. There was no patient injury reported. The suction connector of the device broke off when the user removed the device after the procedure. This is the report regarding the breakage of the suction connector.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-01391 |
| MDR Report Key | 8459248 |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-03-08 |
| Device Manufacturer Date | 2018-10-19 |
| Date Added to Maude | 2019-03-28 |
| 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 | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE USE SUCTION VALVE (STERILE) |
| Generic Name | SINGLE USE SUCTION VALVE |
| Product Code | EOB |
| Date Received | 2019-03-28 |
| Model Number | MAJ-209 |
| Lot Number | H8X13 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-28 |