MAUDE Adverse Event Report: AESCULAP AG & CO. KG CUSHING RONGEUR STR 2X10MM180MM; UTILITY FORCEPS

Model Number FF803R

Device Problems Material Torqued (2980); Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Complaint states: fixation pin (axle) of the jaw was coming out of the instrument during operation, it causes almost injury to the pt because the end of the pin was very sharp.

Manufacturer Narrative

Mfg site eval: upon receipts of the instrument, it was twisted, oem determined the cause of the malfunction was due to handling by the end user.The complaint is not justified and there is no capa required.

• Brand Name: CUSHING RONGEUR STR 2X10MM180MM
• Type of Device: UTILITY FORCEPS
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): AESCULAP AG&CO KG; po box 40; tuttlingen ; GM
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4284206
• MDR Text Key: 5299253
• Report Number: 2916714-2014-00732
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF803R
• Device Catalogue Number: FF803R
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other