MAUDE Adverse Event Report: AESCULAP AG CAIMAN DISP.INSTR.NON ARTICUL.D5/240MM; BIPOLAR TECHNOLOGIES

Model Number	PL738SU
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
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.D5/240mm (part # pl738su) was used during a salpingectomy procedure at the time of a cesarean section (c-section) delivery performed on (b)(6) 2022.According to the complainant, during the bilateral salpingectomy procedure, the tips were sticking and difficult to remove from the tissue.There was an unspecified surgical delay while "repair" and suturing to fallopian tubes was performed.The complaint device was not available to be returned to the manufacturer for evaluation.An additional medical intervention was necessary.Additional information was not provided.The adverse event/malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information/correction: b5 - notification numbers updated h6 - codes updated.Investigation: up to now there is no sample available, therefore an investigation is not possible.Device history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion/preventive measures: root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.The problem of "adherent tissue" can have a number of different causes.If the product is returned at a future date, another investigation will be performed at that time.Based upon the investigation results, a capa is not required.
Event or Problem Description
Update/correction: the adverse event is filed under aag reference (b)(4).

• Brand Name: CAIMAN DISP.INSTR.NON ARTICUL.D5/240MM
• Common Device Name: BIPOLAR TECHNOLOGIES
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16272867
• Report Number: 9610612-2023-00005
• Device Sequence Number: 18000977
• Product Code: GEI
• UDI-Device Identifier: 04046964693939
• UDI-Public: 4046964693939
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K151696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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 Model Number: PL738SU
• Device Catalogue Number: PL738SU
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female