MAUDE Adverse Event Report: AESCULAP AG CAIMAN DISP.INSTR.NON ARTICUL.D5/240MM; SEAL & CUT INSTRUMENTS

Model Number	PL738SU
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
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 procedure performed on (b)(6) 2022.According to the complainant, during surgery for excision of a mediastinal tumor, a piece at the end of the caiman forceps broke off into the patient.The fragment was retrieved from the patient.The complaint device was 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).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information - a2, a3.Investigation results: visual investigation: at the upper jaw of the tip a piece of the peek insulation is chipped off.The chipped off piece was enclosed.The test and analysis was done using a digital camera.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: 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 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.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.Based upon the investigations results a capa is not necessary.

• Brand Name: CAIMAN DISP.INSTR.NON ARTICUL.D5/240MM
• 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: 13517857
• Report Number: 9610612-2022-00020
• Device Sequence Number: 12046569
• Product Code: GEI
• UDI-Device Identifier: 04046964693939
• UDI-Public: 4046964693939
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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 Expiration Date: 07/21/2023
• Device Model Number: PL738SU
• Device Catalogue Number: PL738SU
• Device Lot Number: 52706153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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 Age: 14 YR
• Patient Sex: Female