MAUDE Adverse Event Report: CAREFUSION, INC MIS DIAMOND-FLEX 90° ARTICULATING FORCEPS BABCOCK GRASPER 34CM, 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 89-0500

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) 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.Date of event: date of event was unknown.Awareness date was used as a placeholder.Reporter address and city: address and city were unknown.Unknown was used as a placeholder.

Event Description

It was reported that instrument snapped open during a hepatectomy operation.The device was removed from inside of the patient but there was no patient impact/injury.The procedure was completed successfully.

Manufacturer Narrative

(b)(4) supplemental emdr.Date of event: date of event was unknown.Awareness date was used as a placeholder.Reporter address and city: address and city were unknown.Unknown was used as a placeholder.Upon receipt the returned sample received a visual examination and a functional check.The following markings were found on the device: ce, snowden pencer, 89-0500, and d01, stainless, and usa.Upon visual examination and functional check, the reported failure mode was confirmed.The device was returned with the ratchet captive missing.The ratchet captive engaged with the ratchet toggle, and was contained within the handle by the ratchet captive leaf spring and leaf spring screw.The leaf spring screw also functioned as a pivot point for left thumb box.The leaf spring also provided the detent action for the ratchet captive.However, the ratchet captive was not returned with the device.The device was received with the ratchet captive missing, the leaf spring secured to the handle, and the leaf spring screw fastened flush with the leaf spring and handle.The leaf spring was found to be strong and in good condition and the threads on the polymer handle for the leaf spring screw were not found to be stripped.Due to the rigidity of the leaf spring, the ratchet captive could not have spontaneously sprung loose from under a properly fastened leaf spring.This meant that either the ratchet captive was missing from the device prior to its use in the surgical field where the failure mode was discovered, or the leaf spring screw was severely loose and had since it was tightened by someone.With an intentional effort to swing the leaf spring free of the cavity for the ratchet captive, the leaf spring screw had to be backed out approximately 1/32 inches from the handle or approximately 2 turns of the screw.For this to occur spontaneously, the screw would have had to have been backed out more at the time of observation.Additionally, based on the age and condition of the device, it had been used several times over the twenty years since the device was originally manufactured in d01 (april 2001), therefore, it must have previously had a ratchet captive in place and functioned properly prior to the failure mode occurring.Therefore, one or more of these scenarios likely occurred, the leaf spring screw was loose and the ratchet captive escaped prior to surgical use, but afterwards the loose leaf spring was noted and the screw fastened down, an attempt to repair the device was performed by a third party in which the ratchet captive was removed and the repair party failed to reinstall the ratchet captive before completing the repair, or the leaf spring was significantly loose at the time the failure mode occurred, and the leaf spring had swung free of the ratchet captive cavity enough to allow the ratchet captive to escape.Lastly, an authentic ratchet captive was installed in the sample to verify that the leaf spring was indeed stiff enough, that the leaf spring screw threading on both the screw and the handle was not stripped, and that the ratchet captive could not escape when the leaf spring screw was properly fastened to the device.Based on the age of the device, the signs of use and wear, the fact that the ratchet captive cannot escape from its cavity within the handle when the leaf spring screw was properly fastened, the most probable root cause of the observed failure mode was a failure to inspect the device for functionality and condition prior to surgical use.Please be advised, per the instructions for use (ifu) for this device, ¿prior to use, inspect device to ensure proper function, insulation, and condition.Do not use device if they do not satisfactorily perform their intended function or have physical damage.¿ additionally, it states, ¿proper care and handling is essential for satisfactory performance of any surgical device.The steps in these instructions for use should be taken to ensure long and trouble-free service from all your surgical devices.Inspect devices before each use for broken, cracked, tarnished surfaces, movement of hinges, and chipped or worn parts.If any of these conditions appear, do not use the device.Return device to authorized repair service center for repair or replacement." h3 other text : device was received and evaluated.

Event Description

It was reported that instrument snapped open during a hepatectomy operation.The device was removed from inside of the patient but there was no patient impact/injury.The procedure was completed successfully.

• Brand Name: MIS DIAMOND-FLEX 90° ARTICULATING FORCEPS BABCOCK GRASPER 34CM, 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 ; 8015652341
• MDR Report Key: 12862642
• MDR Text Key: 281159400
• Report Number: 1423507-2021-00052
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10885403155482
• UDI-Public: (01)10885403155482
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

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
• Device Operator: Health Professional
• Device Model Number: 89-0500
• Device Catalogue Number: 89-0500
• Device Lot Number: K20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other