MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS, LLC ALLIS GRIPPER; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number EA015R

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

Patient Problem Foreign Body In Patient (2687)

Event Date 09/03/2016

Event Type  malfunction  

Event Description

One of the "legs" of an allis gripper broke while being used.The broken piece was located and removed from patient and surgical field.

• Brand Name: ALLIS GRIPPER
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS, LLC; 9999 hamilton blvd.,; bldg 8; breinigsville PA 18031
• MDR Report Key: 6099394
• MDR Text Key: 59772327
• Report Number: 6099394
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: EA015R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2016
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR