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 2012-09-26 for TELESCOPE, 10MM, 0 DEGREE, HD, AUTOCLAVABLE WA53000A manufactured by Olympus Winter & Ibe Gmbh.
[3035571]
The physician performed a laparoscopic oophorocystectomy. During the procedure, the pt suffered a skin burn on her thigh, as the doctor had put the device in a pocket of the drape without switching the light off. The doctor carried out treatment of the burns.
Patient Sequence No: 1, Text Type: D, B5
[10192728]
The device involved in the event has not been returned to mfr for investigation, but has been inspected by the local sales and service organization without observation. As the products of other manufacturers too, the videotelescope heats up at the distal end during light emission. The heating-up effect of the wa53000a is nevertheless in conformance to the requirements of (b)(4). It can be considered basic knowledge for medical professionals to switch-off the videotelescope when not in use, especially when it is put aside or on the pt. For that purpose and to meet customer expectations regarding usability, the product is equipped with a stand-by mode. Appropriate warning message are included in the ifu. The event is an obvious consequence of a use error with rather minor (temporary) consequences. The case will be closed without further actions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2012-00083 |
| MDR Report Key | 2773529 |
| Report Source | 05,06,07 |
| Date Received | 2012-09-26 |
| Date of Report | 2012-11-16 |
| Date of Event | 2011-11-16 |
| Date Mfgr Received | 2012-01-13 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2012-10-16 |
| 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 | MICHAEL PETRICH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22045 |
| Manufacturer Phone | 0669662572 |
| Manufacturer G1 | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TELESCOPE, 10MM, 0 DEGREE, HD, AUTOCLAVABLE |
| Generic Name | OLYMPUS VIDEOTELESCOPE |
| Product Code | FBP |
| Date Received | 2012-09-26 |
| Model Number | WA53000A |
| 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 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-09-26 |