AESCULAP LAPAROSCOPIC GRASPER 123136

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number0001055892-2016-00006
MDR Report Key6162557
Date Received2016-12-09
Date of Report2016-12-09
Date of Event2016-10-26
Date Mfgr Received2016-12-06
Date Added to Maude2016-12-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. CY GROPPER
Manufacturer Street1416 DOGWOOD WAY
Manufacturer CityMEBANE NC 27302
Manufacturer CountryUS
Manufacturer Postal27302
Manufacturer G1SYNERGY HEALTH NORTH AMERICA
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameAESCULAP LAPAROSCOPIC GRASPER
Generic NameLAPAROSCOPIC GRASPER
Product CodeFDE
Date Received2016-12-09
Model Number123136
Catalog Number123136
Lot Number968942001
ID NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYNERGY HEALTH NORTH AMERICA
Manufacturer Address1416 DOGWOOD WAY MEBANE NC 27302 US 27302


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-12-09

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