MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. KNIFE MCO5D MICROFRANCE SUCTION RND 2MM; PFM11

Catalog Number MCO5D

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A doctor reported that on (b)(6) 2018 while adjusting the shaft of the mco5d knife microfrance suction rnd, during first time use, there was a fracture in the connection between two parts.A (b)(6) male patient was prepped for an unspecified surgery.There was no patient contact, patient injury/death alleged.There was approximately 0.5 hour (30 minutes) of delay in surgery.Additional information received on 28dec2018 stated that the surgical delay did not cause an impact to the patient.

Manufacturer Narrative

The device was not returned for evaluation.The device history record (dhr ) shows no anomalies that could be associated with the complaint.Therefore, an investigation can not be carried out because the instrument of the complaint has not been returned.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h6, h10.The device was returned for evaluation.The device was broken at the welding area.The tube with the active part was slightly bent.The cleaning wire was missing.The device history record (dhr) was reviewed and no anomalies that could be associated with the complaint were observed.The reported complaint was confirmed.The breakage was propably due to a bad handling of the device.

• Brand Name: KNIFE MCO5D MICROFRANCE SUCTION RND 2MM
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• MDR Report Key: 8252842
• MDR Text Key: 133351638
• Report Number: 2523190-2019-00003
• Device Sequence Number: 1
• Product Code: JYO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCO5D
• Device Lot Number: 2789466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR