MAUDE Adverse Event Report: AESCULAP AG INSULATED OUTER TUBE 5/5MM 310MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PM973R
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
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 to aesculap inc.That metzenbaum serrated scissors (part # po004r) were used during a urology procedure performed (b)(6) 2021.According to the complainant, during the procedure, the surgeon used the scissors with a monopolar connection to take down some adhesions and it arced near the distal end of the insulation.The system settings were noted as being 30 cut/30 coag.The insulation passed the insulation test during reprocessing prior to the case.No injuries to the patient, the arcing hit the abdominal wall and no bowel was burned.The complaint device was available to be returned to the manufacturer for evaluation.No patient harm was reported as a result of this event.Reporedly, the arcing hit the abdominal wall, but no bowel burn occurred.Although requested, additional information has not been made available.The malfunction is filed under aag reference xc (b)(4).
Additional Manufacturer Narrative
Corrected information - b5 (item code changed + involved components added), d1, d2, d4 (part #, udi), g4 (pma/510(k) number).Investigation results: visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.Visually, the instrument arrived in a used condition.Near the distal end, a damage at the insulation can be found.All components have been forwarded to the q-coordinator of the production plant in charge for investigation.Detailed investigation report attached to corresponding pc notification.Excerpt of investigation report: "actual condition: the outer tube is heavily melted at the distal end on the opposite side to the inscription.Otherwise, the outer tube meets all requirements.Cause: possible user error: the outer tube pm973r was in contact with a very hot surface." 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.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.
Event or Problem Description
Correction/additional information: item code changed to pm973r - insulated outer tube 5/5mm 310mm.Involved components added: po603r - jaw ins.Metzenbaum scissors 5mm 310mm - lot unknown.Po958r - monopolar handle without ratchet - lot unknown.

• Brand Name: INSULATED OUTER TUBE 5/5MM 310MM
• 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: 11308920
• Report Number: 9610612-2021-00073
• Device Sequence Number: 19123950
• Product Code: GEI
• UDI-Device Identifier: 04038653260140
• UDI-Public: 4038653260140
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K001330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021
• 2 Devices were Involved in the Event: 1 2

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 Model Number: PM973R
• Device Catalogue Number: PM973R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PO603R - LOT UNKNOWN; PO958R - LOT UNKNOWN
• Patient Sex: Unknown