MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT INSUFFLATION TUBING WOM LAPARAFLATOR, 10; TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC

Catalog Number C7011

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

The three lots possibly involved in the incident are: lot 202009024, lot 202003194, lot 202008124.Manufacturing dates of the three lots are: lot 202009024 - 02sept2020, lot 202003194 - 19march2020, lot 202008124 - 12august2020.At time of filing, although expected, the reported device has not been received into conmed's complaint system for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of their customer, cardinal health -presource reported issues with the insufflation tubing # c7011, with possibility of 3 lots that could be involved, lot 202009024, lot 202003194 and lot 202008124.It was reported only that the "small end that attaches to the trocar broke off inside the trocar port causing equipment failure and potential patient harm." the information received is noted as event date (b)(6) 2021, "no injury / no death " and "complaint quantity 1" but no other procedural information or detail was provided.To date, although multiple attempts have been made to gather additional information, no clarification has been provided.It is not known if the device in question actually made contact with the patient.There is no indication of patient impact or injury.There was no clarification as to why 3 lots were listed on the complaint notification, there was only 1 event date and quantity of 1 was indicated.The specific lot used in the procedure is unclear and as such, all 3 lots are listed as potentially involved in the one incident and all will be listed on this fda reporting.Even though there is very limited information, this report is being raised on the basis of malfunction with potential for injury upon reoccurrence due to the mention of the tubing end breaking off in the trocar port which is thought to have been in the patient at the time.

Manufacturer Narrative

D4: the udis and expiration dates of the three lots possibly involved in the incident are: lot 202009024 - exp: 01-sep-2025, udi: (b)(4).Lot 202003194 - exp: 18-mar-2025, udi: (b)(4).Lot 202008124 - exp: 11-aug-2025, udi: (b)(4).H10: investigation of the reported event is inconclusive.The device has not been returned for evaluation.No photographic evidence was provided.Therefore, the reported failure cannot be verified, & root cause cannot be identified.The manufacturing documents from the device history recorda of all 3 lot numbers reported have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted of all 3 lot numbers reported and found this is the only complaint these lot numbers and failure mode.(b)(4).Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Additional information was received that notes the exact laparoscopic procedure was not remembered.It is indicated the inner small plastic piece that slides into the trocar gas port broke causing the gas line to leak and not function properly.Dr.Watt noticed the leak and checked the tubing where it was no longer staying connected.Dr watt checked and was unable to reconnect the gas tubing as the middle piece of the tubing snapped off inside the gas port of the trocar.Dr.Watt had to use a snap to remove the plastic middle piece and get new gas tubing.It was at the start of the case and they were just placing trocars and there was no active bleeding.The smaller inner piece was stuck in the trocar and took some time to get it removed so it just delayed the procedure.The broken piece did not contact the patient.Nothing was done out of the ordinary and all normal steps were done.The trocar was fine once dr.Watt pulled the small plastic piece out of it as we couldn't connect new tubing until that happened.The patient was fine- no injury.The additional information does not change the determination of this report.This report is still being raised on the basis of malfunction with potential for injury upon reoccurrence as the broken piece was removed and had no contact with the patient.

• Brand Name: INSUFFLATION TUBING WOM LAPARAFLATOR, 10
• Type of Device: TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, mexico 31136 ; MX 31136
• MDR Report Key: 11924372
• MDR Text Key: 256806156
• Report Number: 3007305485-2021-00284
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C7011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2021
• Patient Sequence Number: 1