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

Catalog Number C-VH-1111

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2017

Event Type  malfunction  

Manufacturer Narrative

(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, that there was an air bubble in the bom 7 mm extended length endoscope.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).Initial reporter name: (b)(6).Email: (b)(6), internal complaint number: tw #(b)(4).Autonumber: # (b)(4).This is a reusable oem device; therefore, a lot history review was not applicable.The certificate of conformance (c of c) was not reviewed as the serial number was not reported.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, that there was an air bubble in the bom 7mm extended length endoscope.The hospital did not report any patient effects.

• Brand Name: BOM 7MM EXTENDED LENGTH ENDOSCOPE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 6736576
• MDR Text Key: 80991601
• Report Number: 2242352-2017-00714
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1