MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC 7MM EXTENDED LENGTH ENDOSCOPE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 7MM EXTENDED LENGTH ENDOSCOPE

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, 7mm extended length endoscope cracked rod lens.Look through the lens, the image is bubbled.The issue with the scope was discovered by sterile processing while cleaning, not during a procedure.No patient involvement.

Manufacturer Narrative

Internal complaint number: (b)(4).The reported device is an oem device therefore , a lot history review was not applicable.The certificate of conformance was reviewed for the serial # (b)(6).The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, 7mm extended length endoscope cracked rod lens.Look through the lens, the image is bubbled.The issue with the scope was discovered by sterile processing while cleaning, not during a procedure.No patient involvement.

• Brand Name: 7MM EXTENDED LENGTH ENDOSCOPE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11236569
• MDR Text Key: 228946212
• Report Number: 2242352-2021-00074
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607567700802
• UDI-Public: 00607567700802
• Combination Product (y/n): N
• PMA/PMN Number: K014250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7MM EXTENDED LENGTH ENDOSCOPE
• Device Catalogue Number: VH-1111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1