MAUDE Adverse Event Report: AESCULAP AG DISPOSABLE BIPOLAR METZ SCISSOR 5/310MM; DISPOSABLE INSTRUMENTS

Model Number	PL700
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
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 disposable bipolar metz scissor 5/310mm (part # pl700) was used during an unknown procedure performed on (b)(6) 2021.According to the complainant, the tip of the outer shaft was split.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: vigilance investigator carried out the pictorial documentation visually and microscopically.Ceramics are broken probably due to an overload situation, e.G.Torsion or leverage during handling.The broken ceramic in combination with the contamination caused leakage currents in the instrument.These currents generated heat, which caused damage to the insulation.To avoid damage to the working tip, especially to the ceramic insulation: do not apply excessives forces and protect the working tip from impacts and knocks (as noted in the instructions for use (ifu)).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 no similar compplaints against the same lot number(s) with this error pattern.Possible.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 3(5)) 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: DISPOSABLE BIPOLAR METZ SCISSOR 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: 11673413
• Report Number: 9610612-2021-00298
• Device Sequence Number: 11526085
• Product Code: GEI
• UDI-Device Identifier: 04038653379651
• UDI-Public: 4038653379651
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001330
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 08/20/2024
• Device Model Number: PL700
• Device Catalogue Number: PL700
• Device Lot Number: 52543141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2019
• 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