MAUDE Adverse Event Report: CONMED MEDICAL AIRSEAL; INSUFFLATOR, LAPROSCOPIC

Model Number AIRSEAL IFS

Device Problems Device Emits Odor (1425); Incorrect, Inadequate or Imprecise Result or Readings (1535); Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2020

Event Type  malfunction  

Event Description

Electrical burning smell noted in operating room 4 during procedure.Hazy light smoke coming from back of airseal unit.Airseal turned off and unplugged.Airseal marked out of service.Manufacturer response for insufflator, airseal ifs (per site reporter).This is part of the wear and tear.It is an identified assembly issue of the device.Such assembly corrected by manufacturer for models after 2017.Power entry module failure.Manufacturer will not consider this as a serious issue, their action was to replace the failing module and not addressing the possibility that it would happen again.

Event Description

Electrical burning smell noted in or4 during procedure.Hazy light smoke coming from back of airseal unit.Airseal turned off and unplugged.Airseal marked out of service.Manufacturer response for insufflator, airseal ifs (per site reporter).This is part of the wear and tear.It is an identified assembly issue of the device.Such assembly corrected by manufacturer for models after 2017.Power entry module failure.Manufacturer will not consider this as a serious issue, their action was to replace the failing module and not addressing the possibility that it would happen again.

• Brand Name: AIRSEAL
• Type of Device: INSUFFLATOR, LAPROSCOPIC
• Manufacturer (Section D): CONMED MEDICAL; 6455 s yosemite st ste 800; greenwood village CO 80111
• MDR Report Key: 10747253
• MDR Text Key: 213414038
• Report Number: 10747253
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRSEAL IFS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2020
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18250 DA