MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG N.A.; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number 11575L

Device Problems Device Damaged Prior to Use (2284); Difficult to Open or Close (2921)

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

Event Date 04/04/2019

Event Type  malfunction  

Event Description

The storz basket extractor fails to open.Per the oral maxillo surgeon feedback "there have been times when the basket, out of the box, is partially deployed and cannot be fully withdrawn.".

• Brand Name: N.A.
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 8802488
• MDR Text Key: 151443391
• Report Number: 8802488
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11575L
• Device Catalogue Number: 11575L
• Device Lot Number: 9319020B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14600 DA