MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-26 for LIGHTCABLE DIAM.4.8 LENGTH:2,5M OP913 manufactured by Aesculap Ag.
[184446072]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report, if available.
Patient Sequence No: 1, Text Type: N, H10
[184446073]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00043 |
| MDR Report Key | 9758688 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-03-23 |
| Date Added to Maude | 2020-02-26 |
| 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 | MS KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHTCABLE DIAM.4.8 LENGTH:2,5M |
| Generic Name | LAPAROSCOPIC SURGERY |
| Product Code | FSS |
| Date Received | 2020-02-26 |
| Returned To Mfg | 2020-02-14 |
| Model Number | OP913 |
| Catalog Number | OP913 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |