MAUDE Adverse Event Report: AESCULAP AG AESCULAP; CLIP, SCALP

Catalog Number FF013P

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 11/15/2017

Event Type  malfunction  

Event Description

Scalpfix loads for this lot number do not work properly.A different lot number of same product was opened to complete the case.Manufacturer response for scalp clip, (brand not provided) (per site reporter).On-line complaint form was filled out.

• Brand Name: AESCULAP
• Type of Device: CLIP, SCALP
• Manufacturer (Section D): AESCULAP AG; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 7244079
• MDR Text Key: 99119654
• Report Number: 7244079
• Device Sequence Number: 1
• Product Code: HBO
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/03/2018

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 Expiration Date: 04/30/2022
• Device Catalogue Number: FF013P
• Device Lot Number: 52336428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1