MAUDE Adverse Event Report: SYNERGY HEALTH NORTH AMERICA AESCULAP LAPAROSCOPIC GRASPER

Model Number 123136

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Moving bowel with prestige grasper and part half of the tip broke off in patient.

• Brand Name: AESCULAP LAPAROSCOPIC GRASPER
• Type of Device: LAPAROSCOPIC GRASPER
• Manufacturer (Section D): SYNERGY HEALTH NORTH AMERICA; 1416 dogwood way; mebane NC 27302
• Manufacturer (Section G): SYNERGY HEALTH NORTH AMERICA
• Manufacturer Contact: cy gropper ; 1416 dogwood way; mebane, NC 27302
• MDR Report Key: 6162557
• MDR Text Key: 62385713
• Report Number: 0001055892-2016-00006
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 123136
• Device Catalogue Number: 123136
• Device Lot Number: 968942001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other