MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SUCTION COAG W/VALVE 5MM INS; ELECTROSURGICAL COAGULATION

Catalog Number 600315

Device Problem Break (1069)

Patient Problem Burn(s) (1757)

Event Date 03/04/2022

Event Type  Injury  

Event Description

A facility reported that the lap suction coagulator w/valve (600315) (peel pack) used on a patient had a break in the insulation, resulting in an unwanted burn to the liver.It was reported that the procedure proceeded as anticipated.No surgical delay or patient death occurred.The following was received via medwatch uf/importer report # mw# (b)(4) on 25-april-2022: lap suction coagulator (peel pack) used on patient had a break in insulation result in in an unwanted burn to liver.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h6, h10.Suction coag w/valve 5mm ins (600315) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.The issue of damaged insulation may be the result of wear or environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

Manufacturer Narrative

Updated fields: g3, g6, h2, h10, h11.Corrected fields: h1.

• Brand Name: SUCTION COAG W/VALVE 5MM INS
• Type of Device: ELECTROSURGICAL COAGULATION
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14319788
• MDR Text Key: 294678578
• Report Number: 3014334038-2022-00083
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• PMA/PMN Number: K932456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 600315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 77 KG