MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 2013-10-11 for 2.3MM 1.0MM 80CM DISPOSABLE ANGIOSCOPE ANG-080-D10K 100326502 manufactured by Applied Medical.
[3940716]
Left fem-pop bypass with insertion of saphenous vein: "disposable angioscope would not display picture during surgical procedure. "
Patient Sequence No: 1, Text Type: D, B5
[11411819]
Investigation summary: the event unit was returned for eval. Upon inspection, engineering confirmed the device displayed a skewed and blurry image. No damage was noted to the unit. Engineering disassembled the unit and found that one eyepiece lens was out of its proper position. All endoscopes undergo 100% visual inspection and are functionally tested during the manufacturing process. It is likely that the lens was not secured in its proper position due to an operator error and became detached inside the eyepiece during shipping and handling of the product. The production team has been notified of this occurrence in order to develop a heightened awareness of the incident. This document represents our initial/final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2013-00383 |
| MDR Report Key | 3466447 |
| Report Source | 04,05,06,07 |
| Date Received | 2013-10-11 |
| Date of Report | 2013-10-09 |
| Date of Event | 2013-08-09 |
| Report Date | 2013-10-09 |
| Date Reported to Mfgr | 2013-08-12 |
| Date Added to Maude | 2013-11-15 |
| 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 | 3 |
| Manufacturer Contact | LAUREN CONTURSI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497136671 |
| Manufacturer G1 | APPLIED MEDICAL |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92688 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.3MM 1.0MM 80CM DISPOSABLE ANGIOSCOPE |
| Generic Name | NONE |
| Product Code | LYK |
| Date Received | 2013-10-11 |
| Returned To Mfg | 2013-08-23 |
| Model Number | ANG-080-D10K |
| Catalog Number | 100326502 |
| Lot Number | 1174936 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | RANCHO SANTA MARGARITA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-11 |