N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 7280732
- MDR report key
- 7280732
- Report number
- 2647580-2018-00830
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-02-02
- Date received
- 2018-02-19
- 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
- LISA HERNANDEZ
- 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 | GIA PREMIUM | APPARATUS, SUTURING, STOMACH AND INTESTINAL | US SURGICAL PUERTO RICO | FHM | 030424L | 030424L | P6L0622X | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-02-19 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLES DID NOT DEPLOY FOR THE RELOAD WAS EMPTY, IT WAS WITHOUT STAPLES. THE SURGEON USED ANOTHER RELOAD FOR THE END OF THE PROCEDURE. NO PATIENT INJURY.
N
Patient 1
ADDITIONAL INFORMATION: EVALUATION SUMMARY POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THE RELOAD DISPLAYED A FULL COMPLEMENT OF STAPLES. DAMAGE WAS NOTED TO THE FIRING KNOB SIDE OF THE KNIFE BLADE CHANNEL. MICROSCOPIC INSPECTION REVEALED NO DAMAGE TO THE KNIFE BLADE. FUNCTIONAL TESTING WAS PRECLUDED DUE TO THE OBSERVED CONDITION OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THIS CONDITION MAY OCCUR IF AN EXCESSIVE FORCE IS APPLIED TO THE KNIFE BLADE ASSEMBLY PRIOR TO FIRING. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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.
D
Patient 1