MAUDE Adverse Event Report: AESCULAP AG CAIMAN DISP.INSTR.NON ARTICUL.D:5/240MM; SEAL & CUT INSTRUMENTS

Model Number	PL718SU
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2021
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 caiman disp.Instr.Non articul.D:5/240mm (part # pl718su) was used during a procedure performed on a (b)(6) 2021.According to the complainant, the trigger was broken.The trigger leaks as soon as it is used.Reportedly, the broken piece was retrieved from the patient's abdomen.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 is filed under (b)(4).Associated medwatch-reports: 9610612-2021-00625 (400526602 - pl718su), 9610612-2021-00626 (400526628 - pl718su), 9610612-2021-00627 (400526595 - pl718su).
Additional Manufacturer Narrative
Correction: based upon investigation results, aag complaint # (b)(4).Was re-evaluated and is no longer considered reportable due to risk file- no malfunction or serious injury.Therefore, this case with the internal reference number cc # (b)(4).Was reportable.Investigation reults we made a visual inspection of the received instrument.Here we found no outwardly damages or defects.In the next step we made a functional test.Here we found, that the locking lever is not working.In the next step we opened the handle to investigate the mechanic components.Here we found that the mechanical interlock between the blade trigger and the clamping handle is broken and the parts are missing.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.Conclusion and measures / preventive measures: based upon the investigation results the problem is most likely usage related.Based upon the investigations results a capa is not necessary.
Event or Problem Description
Associated medwatch-reports: 9610612-2021-00625 (400526602 - pl718su) 9610612-2021-00693 (400526612 - pl718su) 9610612-2021-00626 (400526628 - pl718su).

• Brand Name: CAIMAN DISP.INSTR.NON ARTICUL.D:5/240MM
• Common Device Name: SEAL & CUT 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: 12510269
• Report Number: 9610612-2021-00627
• Device Sequence Number: 17429901
• Product Code: GEI
• UDI-Device Identifier: 04046964287176
• UDI-Public: 4046964287176
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K130596
• 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): 11/05/2021

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: 12/09/2021
• Device Model Number: PL718SU
• Device Catalogue Number: PL718SU
• Device Lot Number: 52578819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• 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