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

Model Number	172016
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: 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
• Report Number: 3003139373-2022-00001
• Device Sequence Number: 4577064
• Product Code: FHO
• UDI-Device Identifier: 20884521080819
• UDI-Public: 20884521080819
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K863330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 01/03/2022
• Date Device Manufactured: 10/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female