MAUDE Adverse Event Report: AESCULAP AG DISP.SCISS.SHAFT SLIGHT CVD.D:5/310MM; DISPOSABLE INSTRUMENTS

Model Number	PO885SU
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with po885su - disp.Sciss.Shaft slight cvd.D:5/310mm.According to the complaint description, the disposable scissor tip broke off into the patient's abdomen.The broken tip was removed from the surgical field.This occurred during a laparoscopic cholecystectomy procedure.A grasper was used to remove the fragment; another scissor was opened and the surgery was completed.An additional medical intervention was necessary.All available information has been provided.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: investigation was carried our visually and microscopically.Here we found a broken cutting edge.The fracture surface and the fracture pattern shows no abnormalities.No pores, inclusions or foreign bodies could be found on the point of rupture.A subject matter expert did a labor analysis regarding the material investigation.The results were without any conspicuities.Futhermore the hardness test did not reveal any abnormalities.Breakage was caused due to an overload situation.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 no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 6(10) x probability of occurrence 2 (10)) 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.

• Brand Name: DISP.SCISS.SHAFT SLIGHT CVD.D:5/310MM
• Common Device Name: DISPOSABLE INSTRUMENTS
• 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: 11983472
• Report Number: 9610612-2021-00431
• Device Sequence Number: 3831612
• Product Code: GEI
• UDI-Device Identifier: 04046963605469
• UDI-Public: 4046963605469
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K014207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2026
• Device Model Number: PO885SU
• Device Catalogue Number: PO885SU
• Device Lot Number: 52659429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown