MAUDE Adverse Event Report: ONKOS SURGICAL MALE-FEMALE MIDSECTION TRIAL; INSTRUMENT

Model Number 25100050E

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint is pending investigation.If additional information is made available this report will be supplemented.

Event Description

Sales representative reported that an instrument was damaged and a replacement was needed.

Event Description

Sales representative reported that an instrument was damaged and a replacement was needed.

Manufacturer Narrative

Complaint is pending investigation.If additional information is made available this report will be supplemented.Part information was identified and included in the report.

• Brand Name: MALE-FEMALE MIDSECTION TRIAL
• Type of Device: INSTRUMENT
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• MDR Report Key: 11334905
• MDR Text Key: 233455532
• Report Number: 3013450937-2021-00003
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25100050E
• Device Catalogue Number: 25100050E
• Device Lot Number: 1488330
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1