MAUDE Adverse Event Report: AESCULAP AG CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PL720SU
Medical Device Problem Code	Failure to Sense (1559)
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.D:5/360mm (part # pl720su) was used during a procedure performed on an unknown date.According to the complainant, after the physician turned on the generator and connected the device, the clamp failed to seal the tissue.Reportedly, a generator error occurred in a way that resembled metal in the jaw or the jaws being opened.The physician disconnected the clamp and turned off the generator, and then restarted the unit, but the issue recurred.The procedure was able to be continued and successfully completed using another of the same device.The clamp used in the sequence had no issues.The complaint device has not been 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 cc (b)(4).
Additional Manufacturer Narrative
Updated: d4 - expiration date; d9- product receipt date; h4 - production date.Investigation results: first we made a visible inspection of the jaw.Except the heavy soiling (blood and tissue) we found no abnormities like burned or charred peak.Then we checked the mechanical function.The clamping and the cutting function worked well.In the next step we connected the instrument with an rf- generator "gn 200", snr.(b)(6), and checked the electrical functions: test step: generator- announcement: result: activation with open jaw."regrasp open".O.K.Activation with wet tissue."sealing".O.K.Activation with closed jaw."regrasp open".O.K.Activation with tin-foil in jaw."regrasp short".O.K.In the next step we checked the function and the resistance of the system.Therefore we cleaned the jaw with hydrogen peroxide.Then we connected the instrument to the module box and measured the voltage drop over the instrument.With the voltage drop and the known current, it is possible to calculate the real resistance on load operation.Result: resistance on load operation 1 a: 3,25.The upper limit of the resistance of the complete instrument is 4,0 and the determined value therefore in specification.Next with a clearance gauge we checked the clearance between the upper and the under jaw in closed position.The values are within specification.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.Review of the complaint history revealed that there are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale/conclusion and root cause: because the caiman system is validated, and the complained instrument is without any deviation to the function relevant parameters, a clear conclusion cannot be drawn.Possible causes for insufficient sealing are: - insufficient cleaning of the electrodes (usage).- blood clotting disorder (patient).- cutting before the end of sealing cycle signal (usage).- choice of the wrong parameter (standard/plus - mode).Corrective action: based upon the investigations results a capa is not necessary.

• Brand Name: CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 12165736
• Report Number: 9610612-2021-00491
• Device Sequence Number: 3704762
• Product Code: GEI
• UDI-Device Identifier: 04046964013744
• UDI-Public: 4046964013744
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K130596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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: 11/05/2022
• Device Model Number: PL720SU
• Device Catalogue Number: PL720SU
• Device Lot Number: 52648964
• 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: 06/15/2021
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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: Unknown