MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH & NEPHEW 500 INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Model Number	72203994
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during use in a bi-lateral inguinal hernia repair using the smith & nephew 500 insufflator resulted in a over gassing of the patient.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting.The legal manufacturer for this product, northgate technologies inc., will review the event and determine reportability.They will report to the food and drug administration and any other authorities as deemed necessary.

• Brand Name: SMITH & NEPHEW 500 INSUFFLATOR
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11725555
• Report Number: 1643264-2021-01547
• Device Sequence Number: 14416679
• Product Code: HIF
• UDI-Device Identifier: 03596010673497
• UDI-Public: 03596010673497
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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 Model Number: 72203994
• Device Catalogue Number: 72203994
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1