MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-02-27 for LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE WA03310A manufactured by Olympus Winter & Ibe Gmbh.
[137246434]
The suspect medical device has not yet been returned to olympus for evaluation/investigation. Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown. However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[137246435]
Olympus was informed that during a therapeutic total laparoscopic hysterectomy (tlh), the patient sustained a burn on the inner thigh which required further treatment. No further information was provided and there was no report about a malfunction of any of the medical devices. The intended procedure was completed with the same set of equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2019-00051 |
| MDR Report Key | 8373476 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-02-27 |
| Date of Report | 2019-04-08 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-02-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL WLADOW |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22045 |
| Manufacturer Phone | 4940669662 |
| Manufacturer G1 | SCHOTT AG |
| Manufacturer Street | HATTENBERGSTRASSE 10 |
| Manufacturer City | MAINZ |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE |
| Generic Name | LIGHT GUIDE AND ACCESSORIES |
| Product Code | HBI |
| Date Received | 2019-02-27 |
| Model Number | WA03310A |
| Catalog Number | WA03310A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-27 |