MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-04-17 for OLYMPUS LAB AUTOMATION SYSTEM OLA2500 NA manufactured by Olympus Life Science Research Europa.
[852101]
It was reported that an operator sustained a left hand injury when trying to adjust a pipette tip while the instrument was operating. The injury required 9 stitches, a tetanus shot, and mri. No information has been received to suggest any ill effects associated with the injury.
Patient Sequence No: 1, Text Type: D, B5
[8061550]
The ola2500 user's guide warns (in multiple locations) the user of injury from moving components if the system is not placed in the stop mode before performing service activity, and the possibility that the system could begin moving without warning if this measure is not taken. Training reinforces these precautions and instructions in addition, a safety warning sticker is fixed to the cover to alert operator to "keep hands away from moving parts. " the accident report indicate the operator did not put the system in stop mode prior to placing his hand inside the perform a service activity. Employee admitted failure to follow precautions and instructions that contributed to the event. Safety related site procedures were also disregarded. The system was inspected by an olympus field service engineer and performed as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004148966-2008-00002 |
| MDR Report Key | 1031783 |
| Report Source | 05,06,07 |
| Date Received | 2008-04-17 |
| Date of Report | 2008-04-04 |
| Date of Event | 2008-03-14 |
| Date Mfgr Received | 2008-03-14 |
| Device Manufacturer Date | 2007-11-21 |
| Date Added to Maude | 2010-03-27 |
| 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 | 0 |
| Manufacturer Contact | LAURA TYLER (BY BEV HARDING) |
| Manufacturer Street | 3500 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer Phone | 9726194710 |
| Manufacturer G1 | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH |
| Manufacturer Street | BOETZINGERSTR 31 |
| Manufacturer City | FREIBURG 79111 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS LAB AUTOMATION SYSTEM |
| Generic Name | CALCULATOR/DATA PROCESSING MODULE |
| Product Code | JJG |
| Date Received | 2008-04-17 |
| Model Number | OLA2500 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS LIFE SCIENCE RESEARCH EUROPA |
| Manufacturer Address | SAUERBRUCHSTR. 50 MUNICH GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-04-17 |