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

Model Number PL579T

Device Problem Material Fragmentation (1261)

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

Event Date 04/04/2022

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 pl579t - challenger ti-p ml-ligat.Clips 12 cartr.According to the complaint description, the clip tip broke while the handle was grasped.The broken piece fell into the patient's body during a urology procedure (used for "ralp").An additional medical intervention was necessary.The piece was retrieved successfully.The adverse event is filed under aag reference (b)(4).Involved components: pl536r - shaft compl.D:10mm l:370mm - lot, unknown.Pl520r - challenger ti-p handle - lot, unknown.

Manufacturer Narrative

Update: d9 - no product return.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

Event Description

Update: leading material changed to pl536r - shaft compl.D:10mm l:370mm ((b)(6)).Involved components: pl520r - challenger ti-p handle - lot unknown ((b)(6)).Pl579t - challenger ti-p ml-ligat.Clips 12 cartr.- lot unknown ((b)(6)).

Manufacturer Narrative

Additional information/ correction: b5 - leading device changed, added new involved components.D10 - added new involved components and lots.Investigation results: the complaint samples (shaft and challenger handle) were provided for investigation in a decontaminated condition.A broken-off jaw part was noted on shaft pl536r.No obvious damages were noted on the challenger handle pl520r.The used titanium clip cassette was not provided for investigation.The provided complaint samples were forwarded to the manufacturing plant for investigation.They were inspected according to guardus test plan.Nominal values + results for shaft pl536r (pl536860): pm *01*: 67,8mm +0,05 /-0,1 result: 67,83 (within specification.) pm *03*: 3,85mm +0,2 /-0 result: 4,25 (out of specification) pm *04*: 7,00 mm -0,10/-0,3 result: not measureable due to broken jaw part pm *05*: 6,5mm +0,1/-0 result: not measureable due to broken jaw part pm *02*: ø 10 mm result: within spec.Magazine retention force: min.4 n result: 2,5 (out of spec.) maintenance: result: 01.2021 root elevation: not measureable due to broken jaw part anomalies: jaw part broken, clip cassette seat polished nominal values + results for challenger handle pl520r: - functional inspection results: not functional (leaking) - leakage rate: max.60 mg co2 per hour with inserted gas cartridge at 24°c +/- 4°c result: out of spec.- number of cycles per gas cartridge: 26 result: out of spec.- pm06 22 +/- 0,3 result: within spec.- connection gauge: result: within spec.- mobility rotation star result: within spec.- maintenance: result: 05.2021 the fracture surface of the broken-off fragment shows an area of crack initiation.It is assumed that material fatigue due to movements of the jaw over time ultimately led to the fracture of the jaw part.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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 2(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: according to the investigation results, a definitive root cause cannot be established.However, a usage-related failure cannot be excluded.The maintenance date for both pl536r and pl520r were ignored.Further, according to the applicable instruction for use, the user shall inspect the products for damages (e.G.Cracks) after the cleaning/disinfection process 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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• 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: 14225006
• MDR Text Key: 290287876
• Report Number: 9610612-2022-00105
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PL520R - CHALLENGER TI-P HANDLE - LOT, UNKNOWN; PL520R - LOT UNKNOWN; PL536R - SHAFT COMPL.D:10MM L:370MM - LOT, UNKNOWN; PL579T - LOT UNKNOWN
• Patient Outcome(s): Required Intervention