MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-09 for AESCULAP LAPAROSCOPIC GRASPER 123136 manufactured by Synergy Health North America.
[62385713]
Sterile processing department manager originally reported that the laparoscopic grasper was identified as broken during the procedure set-up protocol. Upon further investigation, it was determined that the laparoscopic grasper distal tip broke intraoperatively. Broken tip was retrieved immediately, removed from the patient, and procedure continued. There were no reported adverse outcomes related to this event. Since the original instrument was not provided for further investigation, six randomly selected laparoscopic graspers were pulled from the finished goods inventory in order to replicate the same findings as originally reported. All graspers were intact and functioned as originally intended. Laparoscopic grasper distal tip breakage may occur if use of excessive force was applied while the device was entered into the tissue. Other possible cause may be related to the incorrect position of the grasper while applying the end user? S forces. Aesculap, the oem, was notified on december 09, 2016.
Patient Sequence No: 1, Text Type: N, H10
[62385714]
Moving bowel with prestige grasper and part half of the tip broke off in patient.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 0001055892-2016-00006 |
MDR Report Key | 6162557 |
Date Received | 2016-12-09 |
Date of Report | 2016-12-09 |
Date of Event | 2016-10-26 |
Date Mfgr Received | 2016-12-06 |
Date Added to Maude | 2016-12-09 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. CY GROPPER |
Manufacturer Street | 1416 DOGWOOD WAY |
Manufacturer City | MEBANE NC 27302 |
Manufacturer Country | US |
Manufacturer Postal | 27302 |
Manufacturer G1 | SYNERGY HEALTH NORTH AMERICA |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | AESCULAP LAPAROSCOPIC GRASPER |
Generic Name | LAPAROSCOPIC GRASPER |
Product Code | FDE |
Date Received | 2016-12-09 |
Model Number | 123136 |
Catalog Number | 123136 |
Lot Number | 968942001 |
ID Number | NI |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SYNERGY HEALTH NORTH AMERICA |
Manufacturer Address | 1416 DOGWOOD WAY MEBANE NC 27302 US 27302 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2016-12-09 |