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 Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

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 had a crack and needs to be repaired.Due to crack of the lens, they were unable to see due to blurriness.They were informed that we have no repair options for the vh-1111 scope.That scope is out of its one year warranty.It was purchased (b)(4) 2016, (b)(4).The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).This is a reusable oem device; therefore, a lot history review was not applicable.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure 7mm extended length endoscope had a crack and needs to be repaired.Due to crack of the lens, they were unable to see due to blurriness.They were informed that we have no repair options for the vh-1111 scope.That scope is out of its one year warranty.It was purchased nov/21/16, po# 391241, order # 6910289638.The hospital did not report any patient effects.

• 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: 10254123
• MDR Text Key: 199306157
• Report Number: 2242352-2020-00603
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• 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: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1