FDA Adverse Event
Injury
Summary report: N
ENDO STITCH 10MM SUTURING DEVICE
MDR report key: 1900225
·
Received November 10, 2010
Report
- Report Number
- 1219930-2010-00853
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- October 17, 2010
- Report Date
- October 18, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- KOG
- PMA / PMN Number
- K934738
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: THE ORIGINAL PROCEDURE WAS ON (B)(6) 2010 AND ON (B)(6) 2010, PT WAS BROUGHT BACK TO THE OPERATING ROOM FOR A SUPRA CERVICAL BLEED. PT EXPERIENCED UTERIAN ACCRETA. DIAGNOSTIC LAP WITH EVACUATION OF THE HEMATOMA, CAUTERIZATION AND LIGATION OF SUPRA CERVICAL BLEED. DURING EVACUATION OF HEMATOMA, THE DEVICE DID NOT WORK. A NEW DEVICE AND DLU WAS OPENED TO COMPLETE THE CASE. NO ABNORMAL BLEEDING DUE TO DEVICE, NO DELAY IN OPERATING ROOM TIME OR TISSUE DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO STITCH 10MM SUTURING DEVICE | DISPOSABLE SUTURING DEVICE | KOG | UNITED STATES SURGICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | (B)(4)| ENDO STITCH POLYSORB 0 48 U/D DLU SU, LOT# UNK |