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 2020-01-02 for XPS? BLADE 1884012HR manufactured by Medtronic Xomed Inc..
[173701180]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[173701181]
A health care provider (hcp) reported via a manufacturer representative that in the middle of a septoplasty procedure, the external tip of the product broke off and was first noticed by the nurse when she received it back from the surgeon. When the surgeon checked the nasal cavity, he could not find the tip. After an extensive search and laryngeal mask airway (lma) was removed, x-ray was done and confirmed that the missing tip was in the patient? S stomach. A replacement device was used to finish the procedure. There was a 30-minute delay in the procedure as a result of this event. It was noted that the broken piece remained inside the patient's body. The patient was discharged from theatre.
Patient Sequence No: 1, Text Type: D, B5
[183433156]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183433157]
On follow-up, it was reported that the broken piece was under observation to be passed out by the patient per rectum.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00004 |
| MDR Report Key | 9537825 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-02 |
| Date of Report | 2020-02-21 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-01-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPS? BLADE |
| Generic Name | BUR, EAR, NOSE AND THROAT |
| Product Code | EQJ |
| Date Received | 2020-01-02 |
| Returned To Mfg | 2020-01-15 |
| Model Number | 1884012HR |
| Catalog Number | 1884012HR |
| Lot Number | 0217663583 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-02 |