MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	IAS8-120LP
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
This complaint was created by the finding of maude report number (b)(4).The account and contact information for this report are not known.The current complaint database has been researched for this event and there were no findings.The ias8-120lp, 8 mm access port & low profile obturator was being used on (b)(6) 2024 and ¿part of the airseal access port broke off inside of patient's abdomen during robotic, laparoscopic procedure.The piece was retrieved; no harm noted to patient.".There was no report of impact or injury to the patient or user.This was reported as a device malfunction not an adverse event.The reporter remained anonymous.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: b5 "part of the airseal access port broke off inside of patient's abdomen during robotic, laparoscopic procedure.The piece was retrieved; no harm noted to patient." was corrected to "air seal plastic seal ripped and parts of it went into patient's cavity.Plastic seal was recovered before closing of the cavity.".Manufacturer narrative: the device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 71 reports, regarding 71 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: once partial entry has been accomplished, very little force is required to complete entry.Excessive force may cause injury to underlying anatomic structures.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
This complaint was created by the finding of maude report number: (b)(4).The account and contact information for this report are not known.The current complaint database has been researched for this event and there were no findings.The ias8-120lp, 8 mm access port & low-profile obturator was being used on (b)(6) 2024 and "air seal plastic seal ripped and parts of it went into patient's cavity.Plastic seal was recovered before closing of the cavity.".There was no report of impact or injury to the patient or user.This was reported as a device malfunction not an adverse event.The reporter remained anonymous.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: AIRSEAL
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 20795457
• Report Number: 3007305485-2024-00188
• Device Sequence Number: 18094960
• Product Code: GCJ
• UDI-Device Identifier: 10845854045718
• UDI-Public: (01)10845854045718(17)261204(10)202312055
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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 Catalogue Number: IAS8-120LP
• Device Lot Number: 202312055
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2023
• 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 Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic