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

Model Number PL569T

Device Problem Material Separation (1562)

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

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a ligating clips m/l 12/box (part # pl569t) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the procedure, when the device was compressed, the top broke off and ended up in the patient.The fragment was retrieved and then the procedure was continued and successfully completed.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: investigation was carried out visually and microscopically.A broken off nose was detected.The instrument provided was in a used condition.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that 3 similar complaints have been filed against products from this batch number (same customer).The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: according to the quality standard a material defect and a production error can be excluded.There are no hints of a pre-damage or similar.Investigations leads to the assumption that the mentioned deviation was caused by an improper handling.The broken off nose can most probably cause by exerting to much force on the nose of the cartridge.If the surgeon pushes the nose of the cartridge into the tissue and then applicate a clip, it can be the possibility that the nose breaks off.Based upon historically grown product experience and due to different simulation, this leads to the described errors.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the problem is most probably usage- related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• 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: 12844614
• MDR Text Key: 281511677
• Report Number: 9610612-2021-00689
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 04038653341375
• UDI-Public: 4038653341375
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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: 52712773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• 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 Age: 31 YR
• Patient Sex: Female