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	04/19/2021
Type of Reportable Event	Malfunction
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 root of one of the cut edges broke after tissue dissection with energization 2-3 times in the lapa sigmoid colon , when ns wiped with wet gauze.There was no described patient harm.Additional information was not available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results visual investigation vigilance investigator carried out the pictorial documentation visually and microscopically.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.Furthermore the broken off blade has been forwarded to material testing labour for hardness and material testing.There are no signs for an manufacturer or design related error.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.Review of the complaint history revealed that seven similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) probability of occurrence(1)) 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.Visual investigation and hardness test indicated that the quality requirements are within the specified tolerance range.It is almost certain that a mechanical overload situation led to the breakage.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
• MDR Report Key: 11841642
• Report Number: 9610612-2021-00384
• Device Sequence Number: 4545915
• Product Code: GEI
• UDI-Device Identifier: 04046963605469
• UDI-Public: 4046963605469
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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 Model Number: PO885SU
• Device Catalogue Number: PO885SU
• Device Lot Number: 52647760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1