MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.; LIGATION / VESSEL CLIPS

Model Number PL579T

Device Problem Unintended Ejection (1234)

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

Event Type  Injury  

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 challenger ti-p ml-ligat.Clips 12 cartr (part # pl579t) was used during a procedure performed on an unknown date.According to the complainant, the device is used in laparoscopic cholecyst resection procedures.The problem encountered was the dislocation of the clip blister (pl579t) from the instrument, when using the device.When applying the second / third clip, the handling mechanism jams and this blockage causes the blister to dislodge and fall in the patient's abdomen.The complaint device was returned to the manufacturer for evaluation.A surgical delay of fifteen (15) minutes was reported.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Involved components: pl606r - multif.Clip appl.Ti-p 10/370mm f/ml-clip - lot unknown.

Manufacturer Narrative

Investigation results: visual investigation: up to now, pl606r is not available for investigation.Pl579t arrived in a sealed condition.The investigation was carried out visually and microscopically.Here we detected no visible deviation.Furthermore, the products were sent to the quality assurance of the production department for further analysis.Based on the investigation results of the quality assurance of the production department: "no error can be detected on the production side".Batch history review: the device quality and manufacturing history records (dhr) will be checked for the leading device(s) lot number(s) from the quality coordinator of the production plant.The results of the review will be documented in pc notification.If the review shows any conspicuities, the report will be updated and actions will be initiated.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

Involved components: pl606r - multif.Clip appl.Ti-p 10/370mm f/ml-clip - lot unknown.

• Brand Name: CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.
• 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: 13550337
• MDR Text Key: 285770034
• Report Number: 9610612-2022-00055
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 04046963356040
• UDI-Public: 4046963356040
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K081031
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL579T
• Device Catalogue Number: PL579T
• Device Lot Number: 52630777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2020
• 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: PL606R - LOT UNKNOWN; PL606R - LOT UNKNOWN
• Patient Outcome(s): Required Intervention