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

Model Number PL741SU

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported that there was an issue with pl741su - caiman disp.Instr.Articulat.D5/360mm.According to the complainant, the tip of the jaw broke and fell into the patient's abdominal cavity.Patient harm was unknown.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch reports: (b)(4) pl741su.(b)(4) (9610612-2022-00323) pl741su.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

Associated medwatch reports: (b)(4) (9610612-2022-00322) pl741su.(b)(4) (9610612-2022-00323) pl741su.

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results, a capa was not requested.

Manufacturer Narrative

Additional information/correction: b5 - patient harm updated; involved component added.D9 - date returned to manufacturer.D10 -involved component and lot added.H3 - device evaluation.H1 - type of the reportable event.H6 - codes.Investigation results: visual investigation: during a visual inspection we noticed, that the shrink hose is damaged at the distal end.The described failure " could not be confirmed, the tip/ jaw is completely and in a proper condition.The plug of the instrument is cut off, the plug itself was not enclosed.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.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability 1(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale without further knowledge about the circumstances we assume, that the distal end of the instrument was not straightened before removing the instrument out of the patient trough the trocar.This may cause damages on the shrink hose by scratching at the edge of the trocar.A further possible root cause is the usage of a not suitable trocar.Conclusion and measures / preventive measures: based upon the investigation results the root cause is most probably usage-related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

Update: patient harm changed from unknown to additional medical intervention necessary.Involved components added.Associated medwatch reports: 400573199 (9610612-2022-00322) pl741su.400573198 (9610612-2022-00323) pl741su involved components: pl741su - caiman disp.Instr.Articulat.D5/360mm - lot 52748757.Pl740su - caiman disp.Instr.Non articul.D5/360mm - lot 52782874.

• Brand Name: CAIMAN DISP.INSTR.ARTICULAT.D5/360MM
• Type of Device: 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15694486
• MDR Text Key: 307185911
• Report Number: 9610612-2022-00322
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K151696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL741SU
• Device Catalogue Number: PL741SU
• Device Lot Number: 52771236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PL740SU - LOT 52782874; PL741SU - LOT 52748757