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

Model Number 7MM EXTENDED LENGTH ENDOSCOPE

Device Problem Poor Quality Image (1408)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

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 using 7mm extended length endoscope, they noticed image was black.They were informed that we have no repair options for the vh-1111 scope.No patient involvement,.

Manufacturer Narrative

Corrected sections: h6 - patient code changed to no patient involvement.(b)(4).This is a reusable oem device; therefore, a lot history review is not applicable.Based on the serial number provided, we were unable to find when the device was sold to the account.The certificate of conformance (c of c) was not available for review because, the reported serial number does not appear to be included in any of the batches received in maquet wayne.H3 other text : device not returned.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure using 7mm extended length endoscope, they noticed image was black.They were informed that we have no repair options for the vh-1111 scope.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: 10557771
• MDR Text Key: 207724690
• Report Number: 2242352-2020-00806
• 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: 09/17/2020

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: 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
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/19/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1