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

Model Number PM438R

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2020

Event Type  malfunction  

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 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.Additional information has been requested, but has not yet been received.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
• Type of Device: ELECTROCAUTERY, GYNECOLOGIC (AND 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: 10782215
• MDR Text Key: 214613056
• Report Number: 9610612-2020-00596
• Device Sequence Number: 1
• Product Code: HGI
• UDI-Device Identifier: 04038653322862
• UDI-Public: 4038653322862
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K003608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM438R
• Device Catalogue Number: PM438R
• Device Lot Number: 62345539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1