MAUDE Adverse Event Report: AESCULAP AG SILICONE RING WITH NEEDLE; HANDHELD PRODUCTS & LIGATION

Model Number	PL595SU
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag tha a silicone ring with needle (part # pl595su) was used during a procedure performed on (b)(6) 2021.According to the complainant, it was reported that the silicone ring was torn.Reportedly, the customer held the needle and set it, but the silicone ring tore.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 adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00683 (400530801 pl595su).9610612-2021-00684 (400530802 pl595su).
Additional Manufacturer Narrative
Associated medwatch reports: pl595su - 400530801 (9610612-2021-00683), pl595su - 400530802 (9610612-2021-00684).Investigation: visual investigation: the analysis of the damage pattern shows a fracture due to overload.No pores, inclusions or foreign bodies could be found at tht damage site.Batch history review: the device quality and manufacturing history records (dhr) 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 2 similar complaints against the same lot number(s).The review of risk assessment revealed that the overall risk level (severity 6(10) x probability of occurrence 3(10)) according to din en iso 14971 is still acceptable.Explanation and rationale: based on the damage pattern, the breakage of the silicone ring was most likely caused by overload by pulling beyond yield strenth.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 defect or manufacturing failure on the basis of the device history records.Based on the investigation results, a capa is not necessary.

• Brand Name: SILICONE RING WITH NEEDLE
• Common Device Name: 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: 12719762
• Report Number: 9610612-2021-00684
• Device Sequence Number: 14416826
• Product Code: GDG
• UDI-Device Identifier: 04046963909338
• UDI-Public: 4046963909338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2024
• Device Model Number: PL595SU
• Device Catalogue Number: PL595SU
• Device Lot Number: 52572608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown