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

Catalog Number	60-6010-005
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the investigation of the device has not been completed.A supplemental and final report will be filed following the completion of the device complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-6010-005 multifunction instrument system (straight grip handle) switch was being used on (b)(6)2025 during a laparoscopic appendectomy and ¿the universal plus straight handle suction cannula is believed to have been suctioning when instrument stuck to bowel, bowel tore when instrument was pulled away by surgeon.Surgeon had to repair bowel.Patient is ok.¿ per further assessment it was reported that the "suction was being used as normally applied during a laparoscopic case.Dr.Sutured the bowel to repair it to it's normal state.He said it was not a major issue but of course needed to be sutured to correct.The surgeon is saying that the button on handpiece was possibly stuck down and therefore activated.They lost visualization (abdominal cavity closed) and they believe it is possibly because suction was on and all co2 was suctioned out." the procedure was completed without the use of an alternate device.There was a ¿minimal¿ delay.The patient was doing "great" and there was no extended hospitalization for the patient.This report is being raised due to the reported injury of torn bowel.
Additional Manufacturer Narrative
Examination of the returned used device 60-6010-005 found that both buttons worked as intended and did not get stuck down during testing.Device functions as intended.A two-year lot history review shows a total of (b)(4) devices for this lot number and failure mode.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.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) 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: use lowest possible power settings on the associated electrosurgical unit capable of achieving the desired surgical effect.Activation time should be as short as possible.Make sure the proper electrosurgical ground pad is used, following the manufacturer¿s directions for proper placement and application.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-6010-005 multifunction instrument system (straight grip handle) switch was being used on (b)(6) 2025 during a laparoscopic appendectomy and ¿the universal plus straight handle suction cannula is believed to have been suctioning when instrument stuck to bowel, bowel tore when instrument was pulled away by surgeon.Surgeon had to repair bowel.Patient is ok.¿ per further assessment it was reported that the "suction was being used as normally applied during a laparoscopic case.Dr.Sutured the bowel to repair it to it's normal state.He said it was not a major issue but of course needed to be sutured to correct.The surgeon is saying that the button on handpiece was possibly stuck down and therefore activated.They lost visualization (abdominal cavity closed) and they believe it is possibly because suction was on and all co2 was suctioned out." the procedure was completed without the use of an alternate device.There was a ¿minimal¿ delay.The patient was doing "great" and there was no extended hospitalization for the patient.This report is being raised due to the reported injury of torn bowel.

• Brand Name: UNIVERSAL PLUS
• 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: 22149894
• Report Number: 3007305485-2025-00096
• Device Sequence Number: 7639310
• Product Code: GCJ
• UDI-Device Identifier: 30653405011730
• UDI-Public: (01)30653405011730(17)291118(10)202411194
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K954056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 60-6010-005
• Device Lot Number: 202411194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic