FDA Adverse Event
Malfunction
Summary report: N
ENDO STITCH* 10MM SUTURING DEVICE
MDR report key: 4810440
·
Received June 2, 2015
Report
- Report Number
- 9612501-2015-00281
- Event Type
- Malfunction
- Date Received
- June 2, 2015
- Date of Event
- May 13, 2015
- Report Date
- May 22, 2015
- Manufacturer
- COVIDIEN
- Product Code
- KOG
- PMA / PMN Number
- K934738
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: THORACOTOMY ACCORDING TO THE REPORTER: AT THE TIME OF SUTURING, THE NEEDLE FELL OFF THE DEVICE. USED ANOTHER DEVICE WITHOUT FURTHER CONSEQUENCE. GENDER, AGE AND WEIGHT ARE NOT AVAILABLE. NO PATIENT INJURY OR ILL-EFFECTS. NO MEDICAL INTERVENTION REQUIRED. NO UNANTICIPATED TISSUE LOSS, TISSUE DAMAGE OR BLEEDING. NO EXTENSION TO SURGICAL TIME REQUIRED. NOTHING FELL IN THE SURGICAL CAVITY. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 355787 | ENDO STITCH* 10MM SUTURING DEVICE | SINGLE USE SUTURING DEVICE | KOG | COVIDIEN | 173016 | J4M0278X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |