MAUDE Adverse Event Report: MAQUET CV VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-4000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

(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 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 during an endoscopic vein harvesting procedure, vasoview hemopro 2 jaws separated from the silicone tip during use.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.Microscopic inspection showed the heater wire was flexed away and detached from the tip but remained attached at the base.The harvesting tool was bent/damaged/broken on 2 locations along the shaft.One proximal from the handle and another proximal to the jaws.Charred tissue was evident on the heater wire.Traces of blood were observed on the tool handle as well as on the jaws.Based on the returned condition of the device and the results of the evaluation, the reported failure mode "bent wire" was confirmed.The analyzed failure modes "bent shaft" and "break, shaft" were also confirmed.The certificate of conformance was reviewed for the analyzed failure modes ¿bent shaft¿ and "break, shaft." the vendors certify that all the device lots manufactured conforms to all the applicable product specifications.There were no non-conformities observed in the device lot.Specific actions for the reported failure mode "bent wire" are being maintained and documented under maquet¿s failure investigation report (fir) system.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 jaws separated from the silicone tip during use.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: VASOVIEW HEMOPRO 2
• 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: 6992916
• MDR Text Key: 91304969
• Report Number: 2242352-2017-01014
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2019
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25133847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2017
• 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: 52 YR