MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SUCTION TUBE MCEN134 110MM MALLE WORMALD; PFM11

Catalog Number MCEN134

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that during an unspecified operation, the welded part located about 5 cm from the edge of the malle wormald suction tube (mcen134) was damaged.There was a risk that broken pieces may remain in the body.It was reported that the device was in contact with the patient; however, no adverse patient consequence or delay in procedure occurred.

Event Description

N/a.

Manufacturer Narrative

The malle wormald suction tube (mcen134) was returned for evaluation.Device history record (dhr): product mcen134 with lot no.6015114 was reviewed and no anomalies that could be associated with the complaint were observed.Failure analysis - evaluation of the suction tube verified the complaint reported by the customer as valid.The laser welding (tube on the handle) was broken.The tube was bent.Root cause analysis: there was a little play between the tube and the handle which can weakened the welding.Both tube and handle were within their specification; however, it seems that the customer applies too much strength on the instrument as the tube was bent.

• Brand Name: SUCTION TUBE MCEN134 110MM MALLE WORMALD
• Type of Device: PFM11
• 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: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15651058
• MDR Text Key: 302208897
• Report Number: 3003249645-2022-00044
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCEN134
• Device Lot Number: 6015114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• 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