MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; HANDHELD PRODUCTS & LIGATION

Model Number PL569T

Device Problem Fracture (1260)

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

Event Date 03/09/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with pl569t - ligating clips m/l 12/box.According to the complaint description, the plastic tip present on the item has broken off during the surgery.The tip was retrieved.In the other sterile challenger clips it can be seen that many are shrink, wrapped, bent over and some of them have the tip broken.An additional medical intervention was required.Additional information was not provided nor available.The malfunction is filed under aag reference: (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: during visual examination of the complaint samples it was noted that the nose of the clip cassette is touching the edge of the inner sterile blister.The noses were found to be bent or even broken-off inside the inner sterile blister.The complaint samples were forwarded to the manufacturing plant for further examination.According to the information received from the manufacturing plant, the worker in the packaging department placed the clip cassette incorrectly into the sterile blister, so that the nose was bent or broke-off.The visual inspection after the packaging process failed to detect this deviation.Device history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The current failure rate is within the risk analysis and therefore acceptable according to procedures; severity 3(5) and probability 1(5).Conclusion and preventive measures: based upon the above mentioned investigation findings, it is concluded that the root cause for the reported issue is manufacturing-related.Based upon the investigation results, a deviation has been initiated to further investigate the issue and to assess the need for corrective actions and the potential risk for patients, users and third parties.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Type of Device: HANDHELD PRODUCTS & LIGATION
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16629077
• MDR Text Key: 312145529
• Report Number: 9610612-2023-00067
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Device Lot Number: 52807485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention