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

Catalog Number C-VH-1111

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that after sterilization and cleaning preparation for an endoscopic vein harvesting procedure, bom 7mm extended length endoscope was blurry and needed repairing.Hospital discontinued use of scope and used an alternative scope to complete procedure.Scope was not sent out for repair.No patient involved.

Manufacturer Narrative

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 reviewed.The vendor certifies that this device lot/serial conforms to all applicable product specifications.The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use with no evidence of blood were observed.No visual defects observed.An image quality inspection was performed with an endoscopic video imaging system.Specks and blurry spots were observed on the images.Based on the results of the evaluation, the reported failure mode "poor quality image" was confirmed.

Event Description

The hospital reported that after sterilization and cleaning preparation for an endoscopic vein harvesting procedure, bom 7mm extended length endoscope was blurry and needed repairing.Hospital discontinued use of scope and used an alternative scope to complete procedure.Scope was not sent out for repair.No patient involved.

• 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: 7139808
• MDR Text Key: 96041070
• Report Number: 2242352-2017-01197
• 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: 12/20/2017

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 Catalogue Number: C-VH-1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 02/13/2018
• Supplement Dates FDA Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2017
• 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