MAUDE Adverse Event Report: MAQUET CV ENDOSCOPE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number BOM 7MM EXTENDED LENGTH ENDOSCOPE

Device Problem Material Integrity Problem (2978)

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

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2015 03:15 pm (gmt-4:00) added by (b)(6)): 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 an endoscopic vein harvesting procedure, bom 7mm extended length endoscope had a cloudy lens.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).Lhr: a lot history search is not applicable because this is a reusable, oem device for which the lot number was not provided to us.A ship history is not likely to identify the correct lot for the reported device.(b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, bom 7mm extended length endoscope had a cloudy lens.The hospital did not report any patient effects.

• Brand Name: 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: 5057352
• MDR Text Key: 25673301
• Report Number: 2242352-2015-01050
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BOM 7MM EXTENDED LENGTH ENDOSCOPE
• Device Catalogue Number: C-VH-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2015
• 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