MAUDE Adverse Event Report: MAQUET CV VASO VIEW HEMOPRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-3000

Device Problem Crack (1135)

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

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

Internal complaint number trackwise # (b)(4).Autonumber # (b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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

Summary: the hospital reported that during an endoscopic vein harvesting procedure, the hemopro malfunctioned.A replacement device was used to finish the case.C ring was cracked.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed.The c-ring was intact, and the scope wash tubing was observed to be melted near the c-ring.Microscopic inspection showed melted c-ring cut edges.The scope wash tubing and the c-ring remained attached to the cannula through the retention rib.No visual defects were observed.Evidence of blood and tissue were observed on the c-ring.Blood was observed on the cannula handle, broken c-ring, along the shaft of the cannula.Based on the return condition of the device and the evaluation results, the reported failure "break, c-ring" was confirmed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, the hemopro malfunctioned.A replacement device was used to finish the case.C ring was cracked.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed.The c-ring was intact, and the scope wash tubing was observed to be melted near the c-ring.The scope wash tubing and the c-ring remained attached to the cannula through the retention rib.The scope wash tubing was observed to be bent near the c-ring.Evidence of blood and tissue were observed on the c-ring.Blood was observed on the cannula handle, broken c-ring, along the shaft of the cannula.Based on the return condition of the device and the evaluation results, the reported failure "break, c-ring" was not confirmed but confirmed for "break; scope wash tubing".

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, the hemopro malfunctioned.A replacement device was used to finish the case.C ring was cracked.

• Brand Name: VASO VIEW HEMOPRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 7334036
• MDR Text Key: 102341082
• Report Number: 2242352-2018-00228
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• 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,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2018
• Device Catalogue Number: C-VH-3000
• Device Lot Number: 25133785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 72