MAUDE Adverse Event Report: CONMED UTICA POOLE SUCTION INSTRUMENT (50/CS); TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Catalog Number	0035040
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, 0035040, poole suction instrument (50/cs), was being used during an emergency laparotomy procedure on (b)(6)2022 when it was reported, ¿we experienced some issues with 3 of this product overnight during an emergency laparotomy.Two (2) came apart within the open abdomen, and a third broke during assembly prior to use.I have been able to confirm these are all from the same batch/lot number.¿.The procedure was reported as having been completed without any injury, medical intervention, or hospitalization for the patient.The components were retrieved from the patient by hand causing a 5¿10-minute delay.It was advised that the patient is ¿absolutely fine¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence was provided therefore the reported event cannot be verified.Based upon the provided information, a likely cause for the issue is that the device was not properly assembled however without the device for evaluation the root cause cannot be determined.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.(b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 0035040, poole suction instrument (50/cs), was being used during an emergency laparotomy procedure on (b)(6) 2022 when it was reported, ¿we experienced some issues with 3 of this product overnight during an emergency laparotomy.Two (2) came apart within the open abdomen, and a third broke during assembly prior to use.I have been able to confirm these are all from the same batch/lot number.¿.The procedure was reported as having been completed without any injury, medical intervention, or hospitalization for the patient.The components were retrieved from the patient by hand causing a 5¿10-minute delay.It was advised that the patient is ¿absolutely fine¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: POOLE SUCTION INSTRUMENT (50/CS)
• Common Device Name: TUBE, ASPIRATING, FLEXIBLE, CONNECTING
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 16120164
• Report Number: 1320894-2023-00004
• Device Sequence Number: 8427350
• Product Code: BYY
• UDI-Device Identifier: 20653405000386
• UDI-Public: (01)20653405000386(17)260919(10)202109201
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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: 09/19/2026
• Device Catalogue Number: 0035040
• Device Lot Number: 202109201
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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: Unknown
• Patient Ethnicity: Non Hispanic