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

Catalog Number 89-6112

Device Problem Break (1069)

Patient Problem Internal Organ Perforation (1987)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacture date: dec 2018.Neither a complaint sample or a representative photo of the complaint sample was provided for investigation.The only information about this event and this complaint sample is the more detailed verbal description of the event that was provided by medwatch, and the device history records for the shop orders that produced 89-6112 with a date code of l18.Concerning the design history records (dhr¿s) there were no indications on all 4 dhr¿s of a step being missed, and no non-conforming material reports (ncmr¿s) were attached to those dhr¿s that would indicate that there was a problem with the device in its as finished state.The complaints log was reviewed on 02apr2019 as far back as l18 (december 2018) and no other complaints were identified for any diamond flex retractor product codes with a date code of l18 that would indicate a negative trend in the production of this instrument.Concerning the verbal description of the event provided by medwatch, the device was ¿noted to suddenly unwind¿.This suggests that there was most likely a failure in the articulation (tension) cable or its associated components that resulted in either a full or partial release of tension.Without more information, it cannot be determined if the tension cable, tension screw, tension knob, or cable nipples may have failed, to what extent or why.It is also unclear as to whether the perforation to the liver was caused by contact of the liver to a retractor component upon failure, or if the perforation was caused by contact of the liver to another device within the operational field as a result of the loss in retracting ability of the complaint sample.Without more information, it cannot be determined if the occurrence of the perforation is an indication of what component on the device may have failed.Without at least, a more complete verbal description, representative photographs, or at best the physical complaint sample, the complaint failure mode cannot be confirmed, and a most probable root cause cannot be determined.Customer is advised to return the complaint sample for investigation.Customer is also advised, the instructions for use for this device, ifu cf36-1828, states ¿over-tightening device actuating knob will result in premature device failure.Tighten actuating knob until intended shape is achieved, additional tightening will not improve device performance.¿ it also states ¿avoid mechanical shock or overstressing devices.¿ it cannot be determined if the knob was overtightened, if the device was overstressed, or if mechanical shock occurred, without a complaint sample available for investigation, however, customer should consider these cautions to help prevent a future occurrence.No device received.

Event Description

Retractor broken during retraction of liver.Although requested, no additional information was received from the customer.28mar2019: received a user facility medwatch mw5084636 from fda stating: event date: (b)(6) 2019, serious injury, required intervention, device: l18 89-6112: patient undergoing laparoscopic paraesophageal hernia repair on (b)(6) 2019, left lobe of the liver was retracted laterally to the right in doing this, the retractor was noted to suddenly unwind partially and resulted in a perforation of the left lobe of the liver on removal no parts appeared to be missing, but it was bent in an unusual position bleeding controlled, completed with no permanent harm to patient.

• 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
• Manufacturer (Section G): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061
• MDR Report Key: 8479437
• MDR Text Key: 140928846
• Report Number: 1923569-2019-00002
• 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: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-6112
• Device Lot Number: L18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention