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

Model Number	172015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2021
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 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
• 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
• MDR Report Key: 12304889
• Report Number: 3003139373-2021-00120
• Device Sequence Number: 14775301
• Product Code: FHO
• UDI-Device Identifier: 10884521080805
• UDI-Public: 10884521080805
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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: 08/03/2025
• Device Model Number: 172015
• Device Catalogue Number: 172015
• Device Lot Number: T0H002X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1