MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 APPLYING FORCEPS NON-DETACH; CRANIAL CLOSURE

Model Number FF494R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: usa.It was reported that the forceps would not clamp.It was reported that there was a five (5) minute delay.No harm to the patient reported.

Manufacturer Narrative

Investigation: used test and analysis equipment: panasonic dmc tz8 digital camera.Ats testing equipment.We sent the instrument of testing at our technical service center.They checked the instrument and found the clamp and crimp forces outside the specification.The root cause of the deviation is normal wear and tear of the profile inside the clamping mechanism.Conclusion and root cause: because of wear and tear, the instrument does not have enough grip to tighten the clamps properly.No capa is necessary.

• Brand Name: CRANIOFIX 2 APPLYING FORCEPS NON-DETACH
• Type of Device: CRANIAL CLOSURE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6944057
• MDR Text Key: 90178064
• Report Number: 9610612-2017-00504
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF494R
• Device Catalogue Number: FF494R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/05/2017
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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