MAUDE Adverse Event Report: CAREFUSION, INC D-FLEX TRIANGULAR RETRACTOR 80MM ANG 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 89-6112

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported state of il was chosen as the customer's contact address was not provided.Only information provided was name and name of hospital.A follow up emdr will be submitted upon supplier evaluation or additional information is received.

Event Description

Customer reported that the end of the retractor was sticking out of the protective cap.

Manufacturer Narrative

(b)(6) follow up emdr.Engineer evaluation: device was visually inspected and the lot j03 was verified.This confirmed that the device was over 16 years old.The reported defects of broken wire and protruding wire were confirmed.The wire had split into two separate lengths with approximately 1/4" of it protruding from the distal tip and the other end falling into the handle and could not be seen.The split occurred on the wire between the 1st and 2nd segment from the main tube arrangement.The cause of the split was determined to be fatigue/wear experienced over the lifetime of the device.The protruding wire at the distal end was determined to have happened after the memory wire broke and was caused by repeated use of the device after the break.Continuation of the device's use caused the wire to repeatedly push against the tip until it finally pushed through.No evidence was found that the manufacturing personnel, processes, material, equipment or machinery, environment, or design contributed to the complaint failure mode.Based on the physical evidence, the most probable root cause of the complaint failure mode was wear.A review of the device history record (dhr) was performed and did not identify any negative trends or issues that would have contributed to this issue.H3 other text : evaluation has been performed.

Event Description

The end is sticking out.

• Brand Name: D-FLEX TRIANGULAR RETRACTOR 80MM ANG 5MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 9554321
• MDR Text Key: 202229550
• Report Number: 1423507-2019-00022
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K092684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-6112
• Device Lot Number: J03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other