MAUDE Adverse Event Report: AESCULAP AG CAIMAN DISP.INSTR.NON ARTICUL.D5/360MM; SEAL & CUT INSTRUMENTS

Model Number	PL740SU
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with pl740su - caiman disp.Instr.Non articul.D5/360mm.According to the complaint description, there was sparks on the jaw during use (inside the abdomen and outside).Error message on the generator.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference: (b)(4).
Additional Manufacturer Narrative
Investigation results: without a product no investigation is possible.The device quality and manufacturing history records (dhr) have been checked for all available lot number 52620400 and the products found to be according to our specification valid at the time of production.The definitive root cause for the problem cannot determined, because there is no product available for analysis.After the 8d report results no capa is necessary.
Additional Manufacturer Narrative
Investigation results visible inspection the investigation was performed by the investigator.First they made a visible inspection of the jaw.Except the blood soiling and the charring in the hinge area we found no further abnormities.Then we checked the mechanical function.The clamping and the cutting function worked well.We performed no testing on the rf- generator, because it is well known, that a charring in this area lead to sparks at the jaw and the error- message "regrasp short" on the generator- display.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Review of the complaint history revealed that there is one similar complaints against the same lot number(s).The review of risk assessment revealed that the overall risk level (severity 2(5) probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures/ preventive measures we we assume, that the surgeon tried to cut while the sealing process was not yet fully completed.That leads to an electric short between the electrodes over the blade.The ifu points out to avoid to advance the blade before the sealing cycle is finished.Due to the complaint information and investigation results we assume that the root cause for the deviation is most likely usage related.Based upon the investigation results no capa is necessary.

• Brand Name: CAIMAN DISP.INSTR.NON ARTICUL.D5/360MM
• Common Device Name: SEAL & CUT INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10924685
• Report Number: 9610612-2020-00838
• Device Sequence Number: 2539149
• Product Code: GEI
• UDI-Device Identifier: 04046964693953
• UDI-Public: 4046964693953
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2021

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: 06/28/2022
• Device Model Number: PL740SU
• Device Catalogue Number: PL740SU
• Device Lot Number: 52620400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 11/26/2020; 01/27/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/21/2020; 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1