MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-18 for KII OPTICAL ACCESS SYSTEM manufactured by Applied Medical.
[95379793]
Applied medical kii optical access system: trocar was inserted into patient. Surgeon was using ligaclip appliers and seal of trocar broke off into patient's abdomen. Surgeon retrieved the seal. No adverse impact to the patient. Diagnosis or reason for use: surgery. Event avated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074110 |
| MDR Report Key | 7128550 |
| Date Received | 2017-12-18 |
| Date of Report | 2017-12-15 |
| Date of Event | 2017-12-07 |
| Date Added to Maude | 2017-12-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KII OPTICAL ACCESS SYSTEM |
| Generic Name | TROCAR |
| Product Code | NGY |
| Date Received | 2017-12-18 |
| Lot Number | 1307303 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-18 |