MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MONOPOLAR CABLE 10 FEET; ELECTROSURGICAL COAGULATION

Catalog Number 600290

Device Problem Material Frayed (1262)

Patient Problem Electric Shock (2554)

Event Date 12/01/2021

Event Type  Injury  

Event Description

The following was reported via medwatch uf/importer report# (b)(4).Rn circulator was plugging in the laparoscopic monopolar cord into the cautery unit and was shocked.Upon examination it was noted that there was a small exposed wire in the end of the cord near the end that is plugged into the unit.

Manufacturer Narrative

The reporting facility indicated that the monopolar cable 10 feet (600290) involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

600290 monopolar cable was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; however, it is not a valid integra lot number.The root cause of the reported issue could not be determined.The issue of an exposed wire may be the result of rough handling 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.

• Brand Name: MONOPOLAR CABLE 10 FEET
• 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: 13515938
• MDR Text Key: 285485062
• Report Number: 3014334038-2022-00022
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 600290
• Device Lot Number: 44665 8383.65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2022
• 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: 27 YR
• Patient Sex: Male
• Patient Weight: 129 KG