MAUDE Adverse Event Report: AESCULAP AG AESCULAP CHALLENGER TI-P MULTI FIRE CLIP; CLIP, IMPLANTABLE

Model Number PL520R

Device Problem Crack (1135)

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

Event Date 02/27/2019

Event Type  malfunction  

Event Description

The aesculap handle for the challenger ti-p has cracked.The product number is pl520r.The component that broke is the latch that holds the cartridge in place.

• Brand Name: AESCULAP CHALLENGER TI-P MULTI FIRE CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): AESCULAP AG
• MDR Report Key: 8382203
• MDR Text Key: 137686030
• Report Number: MW5084561
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL520R
• Device Catalogue Number: PL520R
• Device Lot Number: 2019-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1