MAUDE Adverse Event Report: AESCULAP AG JAW INS.BIP.MARYLAND DISS.FEN.5/310MM; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Model Number	PM438R
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: the investigation of the complained device was carried out visually, and microscopically.The devices show similar deviations, or damages.Damaged and broken parts of the ceramic can be found as well as misaligned jaws.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.Investigations lead to the assumption that the ceramic breakages, and the misaligned jaw parts caused by an improper handling due to a mechanical overload situation.Possibly an excessive force has been applied on the instrument or the possibility of torsion or high leverage with the instrument.According to the ifu the following points need to be observed: " [.] to avoid damages to the working tip, especially the ceramic insulation: apply caution when operating the product.Do not apply excessive force.Protect the working tip against knocks and impacts.Use the pin protector when the product is not in use." (excerpt of the ifu).Based on the investigations, and results of the 8d report no capa is necessary.
Event or Problem Description
It was reported that there was an issue with a maryland fixation forceps jaw insert.According to the complainant, the ceramic part of the jaw came off during surgery.No patient complications were reported as a result of the event.Should additional relevant information become available, a supplemental medwatch report will be submitted.The malfunction is filed under aag reference (b)(4).

• Brand Name: JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
• Common Device Name: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10781980
• Report Number: 9610612-2020-00597
• Device Sequence Number: 3884086
• Product Code: HGI
• UDI-Device Identifier: 04038653322862
• UDI-Public: 4038653322862
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K003608
• 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
• Report Date (Section B): 11/03/2020

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 Model Number: PM438R
• Device Catalogue Number: PM438R
• Device Lot Number: 62349686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1