MAUDE Adverse Event Report: AESCULAP AG DISP.COMBINATION INSTR.BIPOLAR D:5/310MM; HANDHELD PRODUCTS & LIGATION

Model Number	PO800SU
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
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.Combination instr.Bipolar d:5/310mm (part # po800su) was used during a procedure performed on (b)(6) 2021.According to the complainant, at the end of laparoscopy, the bipolar scissor broke at its end.This was still in the patient's body at the time of the breakage.No consequence for the patient except the delay of the operating time.Broken part was recovered.No x-ray was necessary.The complaint device has not been 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).
Event or Problem Description
The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information - d5, d9.Investigation results: visual investigation: it is clearly visible, that the blade of the scissor is out of its position.At first, we made a visual inspection of the instrument, especially the jaw and scissor.Here we found, that the scissor blade is out of its regular position.During a further inspection we noticed, that the leading pin of the scissor blade is not in its position in the guiding slot.The broken off components mentioned in the complaint text could not be confirmed, all individual parts are still complete.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.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 product safety case ((b)(4)) was initiated.Any action regarding capa will be addressed with this case.

• Brand Name: DISP.COMBINATION INSTR.BIPOLAR 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: 13017701
• Report Number: 9610612-2021-00773
• Device Sequence Number: 5127361
• Product Code: GEI
• UDI-Device Identifier: 04038653457564
• UDI-Public: 4038653457564
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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: 09/09/2026
• Device Model Number: PO800SU
• Device Catalogue Number: PO800SU
• Device Lot Number: 52713259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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