MAUDE Adverse Event Report: MENTOR TEXAS BECKER 5MM X 26CM LARGE HANDLE CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Catalog Number	BEC526L
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a surgery of unknown type with a becker 5mm x 26cm large handle cannula 5mm x 26cm and tip broke off in the patient during liposuction surgery.The healthcare professional had to find it with x-ray and therefore, had to make another incision.The patient did not experience any injury.
Additional Manufacturer Narrative
On 4/17/2019, it was reported to mentor that it was not possible to perform a proper failure analysis since the cannula was not returned.Nonetheless, the customer provided some pictures of the actual cannula involved in the complaint.Based on the photo, the tip appears broken and fully separated.The complaint was confirmed.No further investigation can be performed at this time.No corrective actions are required.Complaint will be closed.If the complaint device is received in the future, the complaint will be reopened and an investigation will be performed accordingly.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2019, it was reported to mentor that the during a liposuction procedure a becker 5mm 26cm lg cannula tip broke inside of the patient.This resulted in the need for the patient to undergo an intraoperative x ray to locate the tip, resulting in an additional 2 inch (approximately) incision to obtain the tip from the patient's body.This resulted in 30 additional minutes.To the reporter's knowledge, the patient is well.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 4/9/2019, it was reported to mentor that manufacturing record evaluation was performed for the finished device 110930-09 number, and no non-conformance's related to the reported complaint condition were identified.Manufacturer¿s reference number: (b)(4).

• Brand Name: BECKER 5MM X 26CM LARGE HANDLE CANNULA
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8415039
• Report Number: 1645337-2019-09145
• Device Sequence Number: 10830250
• Product Code: MUU
• UDI-Device Identifier: 00081317020745
• UDI-Public: 00081317020745
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K981172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2017
• Device Catalogue Number: BEC526L
• Device Lot Number: 110930-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/18/2019; 04/09/2019; 04/17/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/02/2019; 04/09/2019; 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention