MAUDE Adverse Event Report: CAREFUSION, INC DEBAKEY D-LINE CLAMP 5MM 45CM 25MM JAW; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SP90-5218
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) initial emdr.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 handle came apart during laparoscopic surgery, and the screw is missing.The patient was reported to be unharmed but the screw could not be found.
Event or Problem Description
It was reported that the handle came apart during laparoscopic surgery, and the screw is missing.The patient was reported to be unharmed but the screw could not be found.
Additional Manufacturer Narrative
(b)(4) supplemental emdr.Upon receipt the returned sample received a visual examination and functional check.The following markings were found on the device: 90-5018, ce, a 2-d udi barcode, snowden pencer, usa, and l20.Upon visual examination and functional check, the reported failure mode was confirmed.The handle pivot screw had separated from the device and was not returned with the remainder of the sample.It was reported that the user was not sure if the screw came off during the case or during washing/sterilization prior to the case starting.Due to the relatively tight tolerance between the female hinge and the male hinge of the handle, it was possible that the user was able to operate the jaws open without the screw present, as pulling the thumb bow back, and under the weight of the thumb bow was found to drive the actuating rod ball in the distal direction without completely unseating the thumb bow from the finger bow.Operating the handle closed drives the thumb bow in the distal direction and would be unlikely to unseat a still seated thumb bow.Therefore, it was possible that the screw came out prior to the case, during washing and sterilization, and the user did not notice until enough force was applied in opening the handle that it unseated the thumb bow from the finger bow.A complaint history review was performed, and no other complaints were identified for sp90-5018 devices to indicate a problem with this production lot.This device was part of the dl1 product line, of which all dl1 handles either use this screw or a different one if they are insulated.Over the last 3 years of dl1 complaints, no other instances of this screw separating from the handle were identified.The screw itself secured only to the distal finger bow while providing a pivot point for the rear thumb bow.The surface the thumb bow pivoted around was a smooth cylindrical surface with a tumbled finish.As such, the actuating of the handle opening and closing should do nothing to back out the screw.An unused screw was tested with the sample handle for fit, and was found to fasten into a secure fit with the distal finger bow, without pinching the hinge and restricting the thumb bow movement.The screw required the same approximate force to break loose while backing out as it did to secure in place by fastening in.Even in a slightly fastened state, the screw did not rotate when the handle was actuated, even when the jaws were restricted from closing by the investigators finger.At this point the only two reasonable causes of the failure mode was either, the operator did not adequately fasten the pivot screw, and it backed out with ease, or an adequately fastened screw was backed out by the application of mechanical energy.As there was no history in the last three years of this screw backing out on its own, it was improbable that this one device was not adequately fastened.An explanation for why the pivot screw backed out from the application of mechanical energy would be the potential use of ultrasonic cleaners by the user.The vibrational energy imposed on the device by the ultrasonic waves could vibrate the pivot screw and distal finger bow in such a way that the vibrational motion acted to separate the two components.Based on the absence of a trend to indicate that there was a problem with this product and date code, an absence of any other complaints for this screw backing out in the last three years, the demonstrated ability for the handle to secure a properly fastened pivot screw in place, and the fact that normal surgical use would not act to break the strength and static friction of a properly fastened tension screw, the most probable root cause of the reported failure mode was cleaning in the use of ultrasonic cleaners.Please be advised, per the instructions for use (ifu) for this device, ¿only the cleaning and sterilization processes which are defined within these instructions for use have been validated.¿ ultrasonic cleaning was not a validated cleaning process and may damage devices for which it had not been validated.H3 other text : sample evaluation has been performed.

• Brand Name: DEBAKEY D-LINE CLAMP 5MM 45CM 25MM JAW
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 11813852
• Report Number: 1423507-2021-00032
• Device Sequence Number: 3161142
• Product Code: GCJ
• UDI-Device Identifier: 10885403158797
• UDI-Public: (01)10885403158797
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K930667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: SP90-5218
• Device Catalogue Number: SP90-5218
• Device Lot Number: L20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other