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

Model Number 172016

Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)

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

Event Date 12/17/2021

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 gastroplasty procedure, while at the abdomen initial stage, the needle comes loose inside the packaging.The seal was disengaged when the packaging was opened.A new device was used to resolve the issue.There was no patient injury.

• 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: 13142700
• MDR Text Key: 283095889
• Report Number: 3003139373-2022-00001
• Device Sequence Number: 1
• Product Code: FHO
• UDI-Device Identifier: 20884521080819
• UDI-Public: 20884521080819
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 172016
• Device Catalogue Number: 172016
• Device Lot Number: T9K009X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Date Device Manufactured: 10/16/2019
• 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
• Patient Age: 28 YR
• Patient Sex: Female