MAUDE Adverse Event Report: AESCULAP AG SCALPFIX STERILE; DISPOSABLES

Model Number FF013P

Device Problem Compatibility Problem (2960)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation on-going.Additional investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with product scalpfix sterile.It was reported that the clips don't come out and some fall out.Additional information was not available.The malfunction is filed under aag (b)(4).Associated medwatch- reports: 9610612-2019-00676 ((b)(4) ff013p), 9610612-2019-00677 ((b)(4) ff013p), 9610612-2019-00678 ((b)(4) ff013p), 9610612-2019-00679 ((b)(4) ff013p), 9610612-2019-00680 ((b)(4) ff013p), 9610612-2019-00682 ((b)(4) ff013p), 9610612-2019-00683 ((b)(4) ff013p), 9610612-2019-00684 ((b)(4) ff013p), 9610612-2019-00685 ((b)(4) ff013p), 9610612-2019-00686 ((b)(4) ff013p).

• Brand Name: SCALPFIX STERILE
• Type of Device: DISPOSABLES
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9146137
• MDR Text Key: 176061686
• Report Number: 9610612-2019-00681
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K062012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2019

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: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: FF013P
• Device Catalogue Number: FF013P
• Device Lot Number: 52339178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1