N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 7542809
- MDR report key
- 7542809
- Report number
- 2647580-2018-02693
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-05-17
- Date received
- 2018-05-24
- 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 | ENDO CLINCH II | FORCEPS, OBSTETRICAL | US SURGICAL PUERTO RICO | HDA | 174317 | 174317 | P7G0612PX | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-05-24 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, WHILE GRASPING AND MANIPULATING THE BOWEL, THE TIP OF THE DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
N
Patient 1
EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED: SHAFT FORK WHERE JAW ATTACHES WAS BENT AND DEFORMED. ONE SIDE OF JAW HAD DISENGAGED FROM DEVICE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. REPLICATION OF THE REPORTED CONDITION MAY OCCUR WHEN THE DEVICE IS EXPOSED TO A SIDE FORCE (LEVERAGE) THAT CONSEQUENTLY BENDS OR BREAKS SHAFT FORK WHERE JAW ATTACHES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.