MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for TELEFLEX 728148 manufactured by Teleflex.
[101499283]
During a laparoscopic cholecystectomy one blade of a teleflex laparoscopic fan retractor catalog #728148 broke off of the retractor and fell into the patient's abdominal cavity. The piece was immediately retrieved by the surgeon and all pieces were accounted for. The retractor and broken blade were retained for inspection if necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075601 |
| MDR Report Key | 7305675 |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-27 |
| Date of Event | 2018-02-01 |
| Date Added to Maude | 2018-03-01 |
| 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 | TELEFLEX |
| Generic Name | LAPAROSCOPIC LIVER RETRACTOR |
| Product Code | PKE |
| Date Received | 2018-02-28 |
| Catalog Number | 728148 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | LIMERICK PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-28 |