MAUDE Adverse Event Report: RENOVO, INC. THREADED CANNULA W/OBTURATOR (TRANSLUCENT, PURPLE); LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number TC-214116

Device Problems Nonstandard Device (1420); Problem with Sterilization (1596)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer shipped outer corrugated boxes to the contract sterilizer that include inner boxes that are addressed to the end customer.The company shipped the sterilizer 6 of these outer boxes, but the sterilizer only received 5 out of the 6 boxes.The company waited several days to see if the 6th box would arrive at the sterilizer, but it never did.At that point, the company initiated a claim with (b)(6).In looking at the (b)(6) records, the outer package was received at a (b)(6) facility on (b)(6).On the (b)(6), the inner boxes were picked up from that (b)(6) location and shipped to the customers.It is unknown why the outer box (addressed to the sterilizer) was opened by (b)(6) to expose the 3 inner boxes.As soon as the company was aware that non-sterile components had been delivered to the end users they reached out to instruct the facilities to immediately quarantine the devices and ship them back to the manufacturer as soon as possible.Two of the three sites who had received the non-sterile product had used at least one of the devices.The facility was able to narrow it down to several patients who could have been exposed but not the exact single patient.

Event Description

A non-sterile trocar was used on a patient.

• Brand Name: THREADED CANNULA W/OBTURATOR (TRANSLUCENT, PURPLE)
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): RENOVO, INC.; 340 sw columbia st; bend OR 97702
• Manufacturer Contact: mark wells ; 340 sw columbia st; bend, OR 97702 ; 5414228880
• MDR Report Key: 11613001
• MDR Text Key: 245938224
• Report Number: 3014023545-2021-00002
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Model Number: TC-214116
• Device Catalogue Number: TC-214116
• Device Lot Number: L-008926-16037
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 10054580-01082020-R-001
• Patient Sequence Number: 1
• Patient Age: 60 YR