FDA Adverse Event
Malfunction
Summary report: N
SUTURE PASSOR PRO
MDR report key: 7959014
·
Received October 11, 2018
Report
- Report Number
- 3010570913-2018-00001
- Event Type
- Malfunction
- Date Received
- October 11, 2018
- Date of Event
- June 6, 2018
- Report Date
- October 11, 2018
- Manufacturer
- ADVANCED MEDICAL DESIGN CO., LTD
- Product Code
- HCF
- UDI-DI
- 09349967000366
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FDA REPORT (B)(4): DOCTOR CALLED FROM HIS OFFICE. STATED THAT HE HAD REMOVED THE SHAFT FROM A PATIENT WHO HAD SURGERY IN SHORT STAY ONE MONTH PRIOR. ADDITIONAL INFORMATION: THE DEVICE DID NOT CAUSE SERIOUS INJURY TO THE PATIENT BUT IT DID REQUIRE THE PIECE TO BE REMOVED FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 798331 | SUTURE PASSOR PRO | INSTRUMENT, LIGATURE PASSING AND KNOT TYING | HCF | ADVANCED MEDICAL DESIGN CO., LTD | RSG-14F | 1726156 | 09349967000366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |