MAUDE Adverse Event Report: AESCULAP AG INSULATED OUTER TUBE 5/5MM 310MM; REUSABLE INSTRUMENTS

Model Number	PM973R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.Medwatch report # (b)(4).
Event or Problem Description
It was reported that there was an issue with pm973r - insulated outer tube 5/5mm 310mm as per information received via medwatch (b)(4).According to the complaint description, the insulation of the device was damaged during surgery.The procedure was a robot-assisted laparoscopic hysterectomy and bilateral salpingo-oophorectomy (bso).The surgeon began using a monopolar scissor with cautery to cut an adhesion.Blackened area was noted above the adhesion; it was removed from the sterile field.A ligasure was then opened to continue the dissection.An additional medical intervention was necessary.The device appeared to have cracked insulation.Additional information has been requested but not yet received as of this report.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Involved components: 400513857 po958r monopolar handle without ratchet; 400552865 po603r jaw ins.Metzenbaum scissors 5mm 310mm.Investigation results: visual investigation: the outer tube was heavily melted at the distal end opposite to the inscription.Date of manufacture is 11.2019.It could be possible that the outer tube pm973r was in contact with a very hot surface.This presumption was made by the q-coordinator in a similar case.Additionally, the component po603r has corrosion on side of the cutting edge.In addition, the cutting edge does not close.It could be possible that something has broken off inside the working end.Without further destruction of the product, we cannot draw any conclusion.The involved component po958r has no issues.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, no capa is necessary.

• Brand Name: INSULATED OUTER TUBE 5/5MM 310MM
• Common Device Name: REUSABLE 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: 11629027
• Report Number: 9610612-2021-00295
• Device Sequence Number: 3021066
• Product Code: GEI
• UDI-Device Identifier: 04038653183715
• UDI-Public: 4038653183715
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: PM973R
• Device Catalogue Number: PM973R
• 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: 03/16/2021
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown