MAUDE Adverse Event Report: CELESTICA DE MONTERREY S.A. DE C.V. SURGINEEDLE; PNEUMOPERITONEUM NEEDLE

Model Number 172015

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/10/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic procedure, there was a break in the plastic part of the needle, which is attached to the gas system.It could not have broken because it is used to use.

• Brand Name: SURGINEEDLE
• Type of Device: PNEUMOPERITONEUM NEEDLE
• Manufacturer (Section D): CELESTICA DE MONTERREY S.A. DE C.V.; calle octava #102; parque industrial monterrey; apodaca nuevo leon ; MX
• Manufacturer (Section G): CELESTICA DE MONTERREY S.A. DE C.V.; calle octava #102; parque industrial monterrey; apodaca nuevo leon ; MX
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12304889
• MDR Text Key: 267524647
• Report Number: 3003139373-2021-00120
• Device Sequence Number: 1
• Product Code: FHO
• UDI-Device Identifier: 10884521080805
• UDI-Public: 10884521080805
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K863330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 172015
• Device Catalogue Number: 172015
• Device Lot Number: T0H002X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1