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).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 using 7mm extended length endoscope s/n (b)(4).During decontamination, they noticed blurry fuzzy image.They phoned in asking for scope repair.They were informed that we have no repair options for the vh-1111 scope.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section: b5 -event description, h6- patient codes corrected to "no patient involved." the reported device is an oem device.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 using 7mm extended length endoscope s/n (b)(6).During decontamination, they noticed blurry fuzzy image.They phoned in asking for scope repair.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: 10557775
• MDR Text Key: 207725296
• Report Number: 2242352-2020-00807
• 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

• Date FDA Received: 09/19/2020
• 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: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1