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

Model Number	PO885SU
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
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 that a disp.Sciss.Shaft slight cvd.D:5/310mm (part # po885su) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the surgery, the base of the cutting edge broke.When ns was wiped with wet gauze after tissue dissection (number of times unknown) in the lapa s-shaped rectum, the base of one of the cutting edges broke.The doctor did not apply excessive force during use.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 malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results.Visual investigation.Vigilance investigator carried out the pictorial documentation visually 1 and microscopically 2.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.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 one 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(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based on the investigation results, a material and/or manufacturing related error can beexcluded.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: MONOPOLAR DISPOSABLE SHAFTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11845152
• Report Number: 9610612-2021-00385
• Device Sequence Number: 4545922
• 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): 07/28/2021

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: 05/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1