MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for FOREIGN ARTICLE APG010 FREMD010 manufactured by Aesculap Inc.
[144154522]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[144154523]
It was reported that there was an issue with the scope during surgery. Prior to a procedure, it was noted that the scope was blurry when attached to the camera; the scope was never used on the patient. There was a minor delay of 10 minutes while another instrument was opened and used instead. There was no patient harm or additional intervention needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2019-00014 |
| MDR Report Key | 8580098 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-06-04 |
| Date of Event | 2019-04-03 |
| Date Facility Aware | 2019-05-23 |
| Date Mfgr Received | 2019-05-23 |
| Date Added to Maude | 2019-05-03 |
| 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. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer G1 | AESCULAP INC |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18034 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FOREIGN ARTICLE APG010 |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | FEM |
| Date Received | 2019-05-03 |
| Model Number | FREMD010 |
| Catalog Number | FREMD010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP INC |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-03 |