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 Problem No Patient Involvement (2645)

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, 7mm extended length endoscope was cloudy.No patient involvement.

Manufacturer Narrative

Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, 7mm extended length endoscope was cloudy.No patient involvement.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, 7mm extended length endoscope was cloudy.No patient involvement.

Manufacturer Narrative

Trackwise # 431334.The reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(4).The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.The device was returned to the factory for evaluation on 02/22/2021.An investigation was conducted on 03/15/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The endoscope was observed to be intact, no visual defects were observed.An image quality inspection was performed on 04/26/2021with an endoscopic video imaging system.A clear image was able to be obtained.The image was observed to clear with no visual defects observed.Based on the results of the evaluation, the reported failure "poor quality image" was not confirmed.

• 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: 11378690
• MDR Text Key: 233541033
• Report Number: 2242352-2021-00178
• 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,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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: C-VH-1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1