FDA Adverse Event
Malfunction
Summary report: N
DRAGON TONGUE SUTURE PASSER
MDR report key: 10777411
·
Received November 3, 2020
Report
- Report Number
- 8043971-2020-00820
- Event Type
- Malfunction
- Date Received
- November 3, 2020
- Date of Event
- January 27, 2020
- Report Date
- January 27, 2020
- Manufacturer
- T.A.G. MEDICAL PRODUCTS CORPORATION LTD
- Product Code
- MBI
- UDI-DI
- 01081867402220
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 1
INSTRUCTIONS AND PRECAUTIONS MENTIONED IN THE (B)(4) THAT WERE NOT FOLLOWED. IT WAS A MISUSE BY PHYSICIAN. WE ASSUME THAT WRONG USE AND NOT FOLLOWING THE IFU INSTRUCTIONS IS THE REASON FOR THIS FAILURE.
Description of Event or Problem · 1
DR. (B)(6) ATTEMPTED TO USE DRAGON TONGUE ((B)(6)) TO CLOSE A HIP CAPSULE DURING A SURGERY IN (B)(6). FIRST DEVICE DID NOT ACTUATE OUT OF THE BOX. ANOTHER DEVICE WAS USED AND WAS ABLE TO PASS 2 SUTURES BEFORE IT ALSO STOPPED ACTUATING. A THIRD DEVICE WAS USED WITH NO ISSUES. DEVICES WERE BROUGHT BACK AND UPON FIRST REVIEW IT APPEARS THE PEEK TUBE IS DISENGAGED FROM THE PLASTIC BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1241069 | DRAGON TONGUE SUTURE PASSER | DRAGON TONGUE SUTURE PASSER | MBI | T.A.G. MEDICAL PRODUCTS CORPORATION LTD | 11003984 | 19N05 | 01081867402220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |