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

Model Number 89-6110

Device Problem Material Integrity Problem (2978)

Patient Problem Laceration(s) (1946)

Event Date 09/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4): if further information becomes available a follow up medwatch will be submitted.(b)(4).

Event Description

A maude report was received which stated, "under direct visualization of placing the liver retractor, one of the wires was protruding and lacerated the liver.Sent for repair on (b)(6) 2015." the customer reported, the snowden-pencer articulating triangular retractor was a reusable device that was not available for the investigation.The staff did not notice any defects when assembling the device.Once on the field it was noted that the wire was out and had lacerated the liver.Although asked, no additional information was provided.

Manufacturer Narrative

(b)(4): the 89-6110 complaint device was not returned for evaluation.Attempts had been made to retrieve the instrument and get additional information by our customer advocacy team but were told the device was not releasable and no new information was provided.Based on the provided information that the device was sent into bd¿s repair department on september 10 2015, we were able to review the repair records and identify the product name, code, date code, and lot number; therefore, a dhr review could be performed.Note the device was from july 2004 which makes the instrument 12 years old.In addition, it was found to have been repaired twice before by bd, once in 2012 under repair # (b)(4) for a broken cable and again in 2015 under repair # (b)(4) for a replacement end segment (long tube).Since this device is 12 years old there was an initial concern that the device did not receive some of the improvements to the product design the device has undergone through the years.The repair record in 2012 confirmed the device was repaired to the 2006 improvement of the addition of the nipple feature of the nitinol wire which aided in the prevention of the segments disassembling for the part in the event of a failure.From the provided information it was stated that the wire was protruding out and had lacerated the liver.Historically, these typical failures are indicative of the nitinol wire breaking at the point of retraction or bend out the side of the flexible shaft due to some type of overstress.Bd is unable to determine exactly where and how the device broke since the device was not returned.Without the device to confirm and evaluate the reported failure carefusion is unable to determine the root cause.If the device becomes available the complaint will be re-opened and a more thorough investigation will be performed.A review of the device history record did not reveal any non-conformances.The device passed all acceptance criteria for release.Since the complaint sample was not returned for evaluation, and there is no trend detected for this issue, no further action will be required at this time.Bd will continue to trend and monitor for this reported failure and for this product family.

• Brand Name: D-FLEX TRIANGULAR RETRACTOR 80MM 5MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 5175 south royal atlanta dr; tucker GA 30084
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628063
• MDR Report Key: 5538745
• MDR Text Key: 41574270
• Report Number: 1038548-2016-00076
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-6110
• Device Lot Number: 782070 G04 R2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/09/2004
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other