MAUDE Adverse Event Report: AESCULAP AG CAIMAN DISP.INSTR.ARTICULAT.D5/360MM; BIPOLAR TECHNOLOGIES

Model Number	PL741SU
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
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 caiman disp.Instr.Articulat.D5/360mm (part # pl741su) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the surgery, the shaft/handle of the device broke.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 xc (b)(4).
Additional Manufacturer Narrative
Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.

• Brand Name: CAIMAN DISP.INSTR.ARTICULAT.D5/360MM
• Common Device Name: BIPOLAR TECHNOLOGIES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11564325
• Report Number: 9610612-2021-00289
• Device Sequence Number: 11886450
• Product Code: GEI
• UDI-Device Identifier: 04046964694165
• UDI-Public: 4046964694165
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: 05/18/2022
• Device Model Number: PL741SU
• Device Catalogue Number: PL741SU
• Device Lot Number: 52612721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1