MAUDE Adverse Event Report: AESCULAP AG LIGATURE CLIP 12 MAG.= 144 PCS.; HANDHELD PRODUCTS & LIGATION

Model Number PL572T

Device Problem Material Integrity Problem (2978)

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

Event Date 08/26/2023

Event Type  Injury  

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 the product pl572t - ligature clip 12 mag.= 144 pcs.According to the complaint description, the first clip fell out during applying.During another attempt to apply a clip, the magazine fell out into the patient's abdomen.The parts of the magazine could be removed from the patients abdomen.Additional medical intervention was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Event Description

Update: involved components: pl510r/handle f/pl506r & pl508r - lot unknown pl522r/shaft compl.D:5mm l:310mm - lot unknown.

Manufacturer Narrative

Additional information: b5 - involved components d9 - product receipt date d10 - involved components h3 - evaluation h6 - codes updated investigation: pl572t (leading component): visual examination revealed that the clip cassette was fractured at the rear end.Further, the slider sheet, which is normally assembled inside the clip cassette, was no longer contained in there.Instead, it was returned separately with strong deformations.Assumably, the slider sheet was removed from the clip cassette after it was recovered from the patients abdomen.It remains unclear, what condition had lead to the reported issue.Functional testing of system components: no deviations noted during functional testing using the complaint samples (handle pl510r & shaft pl522r) and a new clip cassette (lot: 62180806).The reported failure mode could not be reproduced.All clips could be fired without issues, none of the clips fell out and the clip cassette sat firmly on the shaft.Batch 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 per procedures; severity was 3(5) and probability 2(5).Conclusion and preventive measures: based upon the above mentioned investigation results, a root cause could not be established.No malfunction or deviation could be detected using the sent in instruments.The reported failure mode could not be reproduced.The magazine retention force of the shaft was found to be within the specified minimum of 2 n, thus the reported detachment of the clip cassette from the shaft cannot be justified.Based upon the investigation results, a capa is not necessary.

• Brand Name: LIGATURE CLIP 12 MAG.= 144 PCS.
• 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17702935
• MDR Text Key: 322886382
• Report Number: 9610612-2023-00205
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL572T
• Device Catalogue Number: PL572T
• Device Lot Number: 52822017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• 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
• Treatment: PL510R - LOT UNKNOWN; PL522R - LOT UNKNOWN
• Patient Outcome(s): Required Intervention