MAUDE Adverse Event Report: AESCULAP AG SHAFT COMPL.D:10MM L:370MM; LIGATION / VESSEL CLIPS

Model Number PL536R

Device Problem Unintended Ejection (1234)

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

Event Date 08/10/2021

Event Type  Injury  

Event Description

It was reported that there was an issue with pl536r - shaft compl.D:10mm l:370mm.According to the complaint description, the cartridge container fell into the patient's cavity intraoperatively.An additional medical intervention was necessary.Additional information was not provided.The adverse event is filed under aag reference (b)(4).Involved components pl520r - challenger ti-p handle (9610612-2021-00613) (b)(4).

Manufacturer Narrative

Based on the investigation results, the leading material and involved component were updated.Investigation: visual investigation: here we detected that the shaft gets a third-party maintenance service, and based on that we can no longer guarantee the specifications of the product.The jaws of the shaft are misaligned.Furthermore, the products have been forwarded to the responsible production department for further analysis.Findings: the stock is generally in very poor condition, the jaws are badly misaligned, the stop plate is torn off on one side, the root protrusion in the clip guide is damaged.The handle is fully functional.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the problem is most probably third party maintenance/repair-related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigation results a capa is not necessary.

• Brand Name: SHAFT COMPL.D:10MM L:370MM
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15695557
• MDR Text Key: 302690447
• Report Number: 9610612-2022-00307
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 04038653241149
• UDI-Public: 4038653241149
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL536R
• Device Catalogue Number: PL536R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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
• Treatment: PL520R - CHALLENGER TI-P HANDLE
• Patient Outcome(s): Required Intervention