N
Patient 1
NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.
MAUDE MDR 9468453
- MDR report key
- 9468453
- Report number
- 2027111-2019-00663
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-11-19
- Date received
- 2019-12-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- WENDY KOBAYASHI
- Address
- 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US
- Phone
- 949-949-9497
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | APPLIED MEDICAL RESOURCES | HET | CB030 | 101419701 | 1361436 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-12-13 | 0 |
Event Narratives#
D
Patient 1
PROCEDURE PERFORMED: LAP CHOLE. CER 1 OF 2 - (B)(4). CER 2 OF 2 - (B)(4). RELATING TO CER (B)(4), A SECOND PAIR OF SCISSORS WERE OPENED AND FOUND TO ALSO BE BLUNT. THESE SCISSORS CAME FROM THE SAME LOT NUMBER AS THOSE IN CER (B)(4). ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON DECEMBER 2, 2019 FROM CUSTOMER RELATIONS (B)(6). THE TWO EVENT SAMPLES HAVE NOT BEEN RETURNED. PATIENT STATUS: PATIENT IS FINE, AND COMPLETELY UNAFFECTED INTERVENTION: PRODUCT WAS REPLACED WITH ANOTHER.