N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 6976138
- MDR report key
- 6976138
- Report number
- 9612501-2017-06485
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-10-04
- Date received
- 2017-10-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- SAHRON MURPHY
- Address
- 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US
- Phone
- 203-203-2034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BLUNTPORT PLUS | GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY | DAVIS & GECK CARIBE LTD | GDH | 179775P | 179775P | J7A1320X | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-10-25 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, PRIOR TO USE THE DEVICE, SURGEON NOTED THAT A RUBBER PART INSIDE BLUNT GRIP WAS DISENGAGED, THEREFORE, THE DEVICE COULD NOT BE USED AT ALL. NOTHING FELL INTO THE PATIENT'S CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEM.
N
Patient 1
EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED; THE INNER SEAL OF THE THREADED ANCHOR WAS PROTRUDING FROM THE DEVICE. THE OBTURATOR AND TROCAR WERE RECEIVED. THE CANNULA WAS NOT RECEIVED. THE CONDITION OF THE DEVICE PRECLUDES FUNCTIONAL TESTING. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. REPLICATION OF THE PROTRUDING SEAL MAY OCCUR WHEN MISHANDLED DURING CLINICAL APPLICATION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.