MAUDE Adverse Event Report: AESCULAP AG CAIMAN MARYLAND ARTICULATING D5/360MM; SEAL & CUT INSTRUMENTS

Model Number	PL771SU
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.D5/360mm (part # pl740su) was used during a laparoscopic hysterectomy procedure performed on an unknown date.According to the complainant, during the procedure, the caiman pl470su device broke inside the patient.A x-ray was performed to retrieve the broken jaw which reportedly added two (2) to three (3) hours to the operation.The complaint device has not been returned to the manufacturer for evaluation.No patient harm was reported as a result of the event.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).
Additional Manufacturer Narrative
Contrary to the original description in the complaint text, we did not receive a pl740su but a pl771su.Investigation: visual investigation: we made a visual inspection of the lower jaw.Here we found a piece of the molded part missing.The pivot jaw itself shows no damages or defects like bending or broken pins.A further magnification of this area shows the wavy and blistered surface of an incomplete molded part.Batch 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.There are no similar complaints against all 5mm instruments.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: the jaw housing was not completely molded.Therefore, the pivot jaw was not reliably fixed in its holder and became loosened during operation.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the reported issue can be traced back to a manufacturing-related failure.A product safety case (psc) will be requested.Any action regarding capa will be addressed with this case.

• Brand Name: CAIMAN MARYLAND ARTICULATING D5/360MM
• 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: 13563081
• Report Number: 9610612-2022-00033
• Device Sequence Number: 11709351
• Product Code: GEI
• UDI-Device Identifier: 04046964693953
• UDI-Public: 4046964693953
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K183180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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: PL771SU
• Device Catalogue Number: PL771SU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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