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

Model Number	PL718SU
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 jaw did not work well.Reportedly, the tip of the jaw "peeled off." 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 aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00625 (400526602 - pl718su), 9610612-2021-00626 (400526628 - pl718su), 9610612-2021-00627 (400526595 - pl718su).
Event or Problem Description
Associated medwatch-reports: 9610612-2021-00625 (400526602 - (b)(6)), 9610612-2021-00626 (400526628 - (b)(6)), 9610612-2021-00627 (400526595 - (b)(6)).
Additional Manufacturer Narrative
Investigation results: visual investigation: we made a visual inspection of the instrument.Here we found, that a part of the peek insulation of the upper jaw is chipped off.In the next step we tested the clamping and cutting function of the instrument.The clamping and cutting function worked well.Batch history review: 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.The review of risk assessment revealed that the overall risk level (severity 2(5) probability of occurrence1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: in line with analysis of this product, we found that the isolation at the tip is broken.The structure of the broken part show no signs of a material failure.Without further knowledge about the circumstances of the failure, we therefore assume that the instrument was overloaded either during the procedure according to our production standards and the device history files, a material failure or a manufacturing error can be excluded.Based on the investigations and results of the 8d report no capa is necessary.
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.
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: 12510266
• Report Number: 9610612-2021-00625
• Device Sequence Number: 5146816
• 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,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: 01/23/2022
• Device Model Number: PL718SU
• Device Catalogue Number: PL718SU
• Device Lot Number: 52587726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/04/2021; 10/07/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 11/03/2021; 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2020
• 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