MAUDE Adverse Event Report: CAREFUSION, INC TAPERED, SP, ERG TA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SP8442
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(6) initial emdr.Upon receipt the returned sample received a visual examination.The following markings were found on the device: sp8442, h18, ce0123, usa, and snowden pencer.Upon initial visual inspection the reported failure mode was confirmed.Although, the device was etched and labeled as sp8442, it possessed the physical jaw assembly that would otherwise be associated with sp8432.A review of the device history record identified an issue that stated that the parts assembled for an order were 8442 and not 8342 which the order was cut for.While this would have been an acceptable corrective action for the issue, the initial observation was incorrect.Based on that statement and the physical attributes of the sample, the investigator noticed that the insert rod length was too long to be an sp8342, and assumed it was an sp8442, without noticing that the jaw was also incorrect and determined that what was actually pulled for an order of sp8342 was insert assembly 8432.Three replacement devices will be issued for this incident.As a result of the initial mispick (pulling a 8432 to satisfy an order which called for 8342), and a failure to notice that both the rod length and jaw were incorrect for 8342, (5) sp8432 assemblies were released as sp8442 under this shop order.Three of these devices were observed as incorrect by the complaint originator and were essentially quarantined by his possession of them.Prior to identifying from which shop order the issue arose from, based on inventory adjustments to the subassemblies for sp8442, and the fact that this was the result of no more than two potential shop orders, it was determined that there were likely only (5) non-conforming devices and the other two were quarantined at the distributor.All 5 non-conforming devices have been returned to st.Louis for evaluation.Based on the physical evidence as well as the documentation for shop order 3152896, the most probable root cause of the observed failure mode was operator error.The picking operator, in execution of the manual process of kitting parts for this shop order incorrectly grabbed a subassembly 8432 instead of 8342 as intended.An employee awareness/training was completed for this situation but the shop order associated with this complaint was picked prior to this employee awareness/training.Sample evaluation completed.
Event or Problem Description
Device was reported to be a sp8432 but was labeled as sp8442.

• Brand Name: TAPERED, SP, ERG TA
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 12238272
• Report Number: 1423507-2021-00040
• Device Sequence Number: 11700177
• Product Code: GCJ
• UDI-Device Identifier: 10885403172298
• UDI-Public: (01)10885403172298
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K991928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: SP8442
• Device Catalogue Number: SP8442
• Device Lot Number: H18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/28/2021
• 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