MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; LAPAROSCOPIC SURGERY

Model Number PL569T

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with ligating clips.According to the customer report: "during a cholecystectomy, the clips have detached from the forceps.Clip fell into the patient's abdomen, breaking at the end.Clinical consequences / actions taken: plastic piece recovered by the surgeon.Applier was not available.Patient harm is unknown.Additional information was not provided nor available / was not available.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

General information: we received a complaint about a malfunction of a ligature clip cartridge.The cartridge was provided for investigation.Unfortunately it has probably been thermally reprocessed by the customer.Consequences for the patient: according to the available information, there were no negative consequences for the patient.Investigation: the cartridge has probably been thermally reprocessed by the customer.Pictures provided by the sales organization are available.Investigation: since the cartridge has probably been reprocessed, an investigation was not possible.The cartridge is deformed, like melted (see figure 6).Based on the pictures available, the cartridge was fractured.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale: an investigation was not possible at the provided cartridge.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Therefore, the root cause of the error is most probably usage related.Probably the breakage of the cartridge was caused by an overload situation during mounting the cartridge.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9729318
• MDR Text Key: 180828725
• Report Number: 9610612-2019-00961
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

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: PL569T
• Device Catalogue Number: PL569T
• Device Lot Number: 52567707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1