MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2013-08-27 for FORCEPS 3711020 TAKAHASHI NASAL 2.5X8MM manufactured by Medtronic Xomed, Inc..
[3952842]
It was reported that during a bilateral turbinate septoplasty, the tip of the jaw of the nasal forceps broke-off inside the patient. They were able to retrieve the fragment with no x-ray, no additional intervention, no additional surgery, and no additional medicine was needed.
Patient Sequence No: 1, Text Type: D, B5
[11013239]
(b)(4): product evaluation: no analysis available; device has not been returned for analysis. Method: no testing methods performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[28309591]
Device received for analysis on september 4, 2013. Evaluation summary: product received by our quality engineers for analysis: one (1) sample(s) without the original product pouch or label was returned. The returned sample had etching, which identified part number as 3711020 (takahashi nasal forceps 2. 5mm x 8mm). From the condition of the returned device, customer use was visible. Upon visual observation, the forceps tip (the tip that can be actuated by handle) was found broken at its proximal end and completely detached from the instrument. The broken edge was observed magnification and indicated the likelihood of mechanical stress / force observed at the break point. Method: microscopic inspection. Results: stress problem.
Patient Sequence No: 1, Text Type: N, H10
[102469545]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00503 |
| MDR Report Key | 3311326 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2013-08-27 |
| Date of Report | 2013-08-05 |
| Date of Event | 2013-08-05 |
| Date Mfgr Received | 2013-09-11 |
| Date Added to Maude | 2013-11-26 |
| 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 | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| 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 | FORCEPS 3711020 TAKAHASHI NASAL 2.5X8MM |
| Generic Name | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2013-08-27 |
| Returned To Mfg | 2013-09-04 |
| Model Number | 3711020 |
| Catalog Number | 3711020 |
| 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 DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-27 |