N
Patient 1
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT, IF AVAILABLE.
MAUDE MDR 9758688
- MDR report key
- 9758688
- Report number
- 9610612-2020-00043
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-12-12
- Date received
- 2020-02-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS KERSTIN ROTHWEILER
- Address
- PO BOX 40 TUTTLINGEN, 78501 GM
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LIGHTCABLE DIAM.4.8 LENGTH:2,5M | LAPAROSCOPIC SURGERY | AESCULAP AG | FSS | OP913 | OP913 | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-26 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH LIGHT CABLE DIAM.4.8 LENGTH. ACCORDING TO THE CUSTOMER DESCRIPTION: "THE FAILURE WAS CAUSED BY INCREASE OF TEMPERATURE AND BURNING OF IMPURITIES ON FIBER OPTIC CABLE OP 913 DUE TO REDUCED LIGHT TRANSMITTANCE. DURING OPERATION THE CABLE WAS IN LIGHT SOURCE OP930, (THE MACHINE AFTER FUNCTIONAL TEST WITHOUT FAULT). THE PATIENT OR STAFF HARM IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER (B)(4).