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

Catalog Number C-VH-1111

Device Problems Structural Problem (2506); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 08/23/2018

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 sterilization/sanitization for an endoscopic vein harvesting procedure using bom 7mm extended length endoscope.It was stated that they used an nx sterrad model to sterilize their vh-1111 endoscope.It was also stated "it is causing scopes to fail and becoming physically compromised".The proximal end of the scope looks as if it is "melting".It was made aware that the nx sterrad model is not listed on getinge instructions for sterilization for vh-1111.No patient involvement.

Manufacturer Narrative

Corrected section: patient code changed to "no patient involvement" internal complaint number: tw# (b)(4).Autonumber: (b)(4).This is a reusable oem device; therefore, a lot history review was not applicable.A lot/serial number was not provided and the specific product lot/serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.

Event Description

The hospital reported that during sterilization/sanitization for an endoscopic vein harvesting procedure using bom 7mm extended length endoscope.It was stated that they used an nx sterrad model to sterilize their vh-1111 endoscope.It was also stated "it is causing scopes to fail and becoming physically compromised".The proximal end of the scope looks as if it is "melting".It was made aware that the nx sterrad model is not listed on getinge instructions for sterilization for vh-1111.No patient involvement.

• 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
• MDR Report Key: 7878702
• MDR Text Key: 120529161
• Report Number: 2242352-2018-00906
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• 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
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1