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

Model Number	89-6112
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial emdr.Date of event was unknown.Bd awareness date was selected.A device is anticipated for investigation.Once the investigation has been completed a supplemental emdr will be submitted for the investigation results.If any additional information is received a supplemental will be submitted with those details.
Event or Problem Description
It was reported that the device failed to hold the liver.
Additional Manufacturer Narrative
Upon receipt the returned sample received a visual examination and a functional check.The following markings were found on the device: snowden pencer, usa, c19, 89-6112, ce012, and a 2-d udi barcode.Upon visual examination the reported failure mode was confirmed.The tension cable had broke into two pieces, both of which were returned with the remainder of the sample.Additionally, a sterilization sleeve was returned.A significant observation about the break in the cable was that the individual strands severed at two points in length along the cable and that these two break planes are approximately.218¿ apart from each other as measured with calibrated calipers.To clarify, all but three strands broke on one plane, the other 3 strands broke at the other.Segment pieces are the flex components at the distal end of the piece that are compressed together by tightening the tension knob.When a cable breaks due to wearing down from friction the individual strands break at relatively different lengths along the cable, yet near each other, and often near the proximal most segment piece.The proximal most segment piece was typically where this occurred because this segment piece had the most amount of cable travel through it as the tension cable was tightened on account of the non-knob end of the cable being fixed.This location would be approximately 18 inches from the proximal end of the cable.Instead, this cable broke approximately 21¿ from the proximal end of the cable.Additionally, when a cable breaks from frictional wear the individual strands break at different locations because the individual strands wear down over time, that was not the case with this sample.The presence of a plane of break indicated that several strands were most likely severed simultaneously and the most likely reason for this to occur was that the distal end with the flex components experienced significant deflection while the device was in a relaxed or semi-relaxed state, pulling the cable over the sharp internal edge of the holes in the segment pieces where the cable runs through.The presence of two break planes approximately.218¿ apart indicated that this most likely occurred at both ends of a single segment piece.The device was only designed to be deflected to the range it achieved when fully actuated, and should be protected from unwanted deflection when not in use by placing the sterilization sleeve over the distal end.Both ends of the cable were pulled from the device and examined and at several points along the cables it can be observed that that the internal edges of the segment pieces bit into the cable along the cable, spaced a segment piece¿s length in distance apart from one another.This further substantiated that the most likely scenario was that the device experienced extreme deflection while in a relaxed state, and that the internal edges of the segment pieces began to bite into the cable in several locations.Additionally, the complaint log and shop orders for 89-6112 with a date code of c19 were reviewed and no other complaints were identified for the other 52 devices that were released with the same product and date code.Lastly the cable was examined for conformance to the product specifications and was found to match the cable diameter specified by the print.Based on the physical evidence of two main planes of breakage for all strands, the absence of a trend indicating an issue with this product code and date code, and no non-conformances observed on the cable, the most probable root cause of the reported failure mode was mechanical overstress.Something most likely deflected the flex end of the device while the flex section was not being protected by the sterilization sleeve, and under this level of deflection and strain the cable started to slice through the cable strands in several locations.It was possible that this damage to the cable occurred prior to the surgery where the device failed, and a few strands held out until an attempt was made to hold the liver during the incident where the device failed.However, based on the consistency in location of cable breakage, it was likely that the level of device articulation that was present when the device failed was the same level of articulation that was present when the damage was done to the cable.Please be advised, per the instructions for use, ¿avoid mechanical shock or overstressing devices.¿ a replacement device will be issued for this incident.H3 other text : evaluation has been performed.
Event or Problem Description
It was reported that the device failed to hold the liver.

• Brand Name: D-FLEX TRIANGULAR RETRACTOR 80MM ANG 5MM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 10862578
• Report Number: 1423507-2020-00056
• Device Sequence Number: 3766181
• Product Code: GCJ
• UDI-Device Identifier: 10885403122835
• UDI-Public: (01)10885403122835
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 89-6112
• Device Catalogue Number: 89-6112
• Device Lot Number: C19
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1