MAUDE Adverse Event Report: AESCULAP AG DISP.SCISS.SHAFT SLIGHT CVD.D:5/310MM; HANDHELD PRODUCTS & LIGATION

Model Number	PO885SU
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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 an unknown date.According to the complainant, it was reported that the surface of the instrument separated while it was passed through the reusable trocar and detached into the patients abdomen.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event / 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 insulation of the used shaft is damaged.Only a picture of the fragments has been provided, but not the fragments itself.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 no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based on the quality standard and the device history records, a material or production related error can be excluded.Such damage to the insulation can be caused by an overload situation.Leverage forces during movement in a trocar can cause shearing of the insulation, a worn trocar-tip can further promote this error pattern.Based upon the investigations results a capa is not necessary.

• Brand Name: DISP.SCISS.SHAFT SLIGHT CVD.D:5/310MM
• 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: 12617742
• Report Number: 9610612-2021-00663
• Device Sequence Number: 1348965
• Product Code: GEI
• UDI-Device Identifier: 04046963605469
• UDI-Public: 4046963605469
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 05/20/2016
• Device Model Number: PO885SU
• Device Catalogue Number: PO885SU
• Device Lot Number: 52688034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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