MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SCISSORS INSERT CEV605G 3PK 350MM; PFM16

Catalog Number CEV605G

Device Problems Misassembled (1398); Misassembly by Users (3133)

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

Event Date 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on september 11, 2015.The investigation included: method: evaluation of actual device, review of device history record, review of complaints history results: dhr review; no nonconformity for this lot.No complaints history for this lot.Conclusion; the breakage must come from a mishandling and not straight disassembly with the tube cev649-5b.A newer version of the tube cev649-5b with a blister prevents scissors deterioration.It was also noted that the tube has been modified by a third party.

Event Description

The sheath of the tube become damage when take off the trocar.There was patient contact, but no injury or death alleged.The event did not lead to an increase of surgery time.

• Brand Name: SCISSORS INSERT CEV605G 3PK 350MM
• Type of Device: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: sonia irizarry
• MDR Report Key: 5095721
• MDR Text Key: 26663057
• Report Number: 2523190-2015-00096
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• PMA/PMN Number: K993655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEV605G
• Device Lot Number: 140902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1