MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.; LAPAROSCOPIC SURGERY

Model Number PL574T

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

Per 3500 a medwatch form 5201770000-2019-8032 received by the fda, there was a device malfunction.It was reported that there was an issue with the challenger clips.During an unspecified procedure, when using the challenger applier, the plastic rack of clips popped out.It was then retrieved from within the patient.Upon closer review of the device, it appeared that the clip cartridge had been loaded properly; however, it fell apart during use.Additional information was not provided.

Manufacturer Narrative

Manufacturing site evaluation: the device is not available for investigation.Pictures were not provided.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: no product was available and therefore it is hardly possible to determine an exact conclusion and root cause.It appears that the cause of the failure is not product related.The root cause could be usage related.Rationale: according to the quality standard and device history records (dhr), a material defect, production, and design error can be excluded.Unfortunately, due to lack of data and without the product we cannot determine the exact cause.There is the possibility that the cartridge has not been mounted correctly.An additional reason could be a clip jam.These could have been caused due to usage error.A clip jam can be caused by too rapid application.And the rapid application can cause a deformed slider sheet.Possibly the clip applicator could be damaged due to a damaged push rod.If further investigations are required, the complained clip and applicator should be returned for examination.

Event Description

Clarification was received: the procedure was a robotic prostatectomy and it was performed as a treatment for prostate cancer.No intervention or x-ray was required due to the malfunction, and the cartridge was retrieved quickly from the patient.Surgery was completed successfully.

• Brand Name: CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8605513
• MDR Text Key: 144967250
• Report Number: 9610612-2019-00322
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K081031
• 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: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52449567
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/28/2019
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR