MAUDE Adverse Event Report: AESCULAP INC LARGE CLIP APPLIER 280MM; LAPAROSCOPIC SURGERY

Model Number PO428-1BR

Device Problem Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report.Investigation on-going, if available.

Event Description

It was reported that there was an issue with the clip appliers.During closure of an anterior lumbar interbody fusion (alif) surgery, the staff noticed that some of the color coding on one of the appliers was missing.This was part of the plastic-like overlay on the finger loop of the devices.There was flaking noted on all 3 devices and the surgeon's were concerned that this could have fallen inside the patient.No fragments were recovered and a decision was made not to reopen the incision.There was no known patient harm and no additional intervention.Associated medwatches: 2916714-2020-00044.2916714-2020-00045.2916714-2020-00046.

Manufacturer Narrative

Investigation results: the complaint device was not available to be forwarded to the manufacturer.A visual examination could not be performed.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Factors that could have contributed to the reported event include: -the nylon clad coating on the appliers will begin to be removed from the instruments after years of use and cleaning -this is also dependent upon the cleaning and sterilization methods used the exact root cause cannot be determined due to lack of product return.Although the investigation did not confirm the failure mode, evidence of product contribution to the reported event was not indicated.If additional information or product becomes available for evaluation, the results will be provided in a supplemental report.

• Brand Name: LARGE CLIP APPLIER 280MM
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 9746863
• MDR Text Key: 181347783
• Report Number: 2916714-2020-00046
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PO428-1BR
• Device Catalogue Number: PO428-1BR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1