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

Catalog Number C-VH-1111

Device Problems Device Operates Differently Than Expected (2913); Moisture or Humidity Problem (2986)

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

Event Type  malfunction  

Manufacturer Narrative

(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 service/testing for an endoscopic vein harvesting procedure, bom 7mm extended length endoscope s/n (b)(4) was allowing moisture inside, the image was dark and cloudy.Hospital called seeking scope repair.(b)(4) contact was provided.

Manufacturer Narrative

(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 (b)(4).

Event Description

The hospital reported that during service/testing for an endoscopic vein harvesting procedure, bom 7mm extended length endoscope s/n (b)(4) was allowing moisture inside, the image was dark and cloudy.Hospital called seeking scope repair.Schoelly imaging contact was provided.

• 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: 6978301
• MDR Text Key: 90985567
• Report Number: 2242352-2017-00997
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• 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?: Yes
• Date Manufacturer Received: 12/05/2017
• Date Device Manufactured: 08/13/2009
• 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