MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT AIRSEAL 5/120MM PORT; INSUFFLATOR, LAPAROSCOPIC

Catalog Number IAS5-120LP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

Additional fda product code: gcj.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.

Event Description

The sales representative reported on behalf of the customer that the ias5-120lp device was being used during a robotic assisted total laparoscopic hysterectomy, bilateral salpingectomy and cystoscopy on (b)(6) 2021 when it was reported that "patient was here on (b)(6) 2021 for a robotic assisted total laparoscopic hysterectomy, bilateral salpingectomy and cystoscopy.According to the tech in the or the obturator for the 8mm airseal was not removed by the assistant surgeon prior to placing the table in extreme trendelenburg and a serosal defect was created in the small bowel that then had to be repaired by a general surgeon." further assessment questions have been sent, but to date no response has been received.The patient status was said to be good.The procedure was completed with an alternate unknown device.This report is being raised on the basis of injury due to serosal defect that had to be repaired.

Manufacturer Narrative

Corrected data: h10: a two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame 826,764 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).

Manufacturer Narrative

The reported event of "obturator not removed prior to repositioning the patient and a serosal defect was created" is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.A 2 year lot history review could not be conducted as a lot number was not provided.A device history review could not be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 3 complaints, 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: ensure that the patient is properly positioned so that organs are away from the penetration site.Direct the airseal access ports tip away from significant vessels and organs.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL 5/120MM PORT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 11424276
• MDR Text Key: 241852293
• Report Number: 3007305485-2021-00112
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2021

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?: No
• Device Operator: No Information
• Device Catalogue Number: IAS5-120LP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 04/02/2021; 05/05/2021
• Supplement Dates FDA Received: 05/03/2021; 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other