MAUDE Adverse Event Report: AESCULAP AG SPARE CUTTER F/GB302R/GB303R/GB307R; HIGHSPEED POWER SYSTEMS

Model Number TE562

Device Problem Retraction Problem (1536)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with te562 - spare cutter f/gb302r/gb303r/gb307r.According to the complaint description, the replacement cutter has "not stopped".Patient harm was unknown.Additional information has been requested.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information/correction: b5 - update provided; h4 - production date.Based upon the investigation results, the case has been re-assessed and found to be non-reportable.There was no product failure found.Investigation results: visual investigation: optically, the perforator is in a used but good condition.The investigation was further carried out by aesculap technical service (ats), following the corresponding test plan for the article number.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.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale: there is no indication for a product failure.Besides signs of wear and tear, no failure could be detected.The perforator works as intended.However, a re-grinding is recommended.Several points can be found within the corresponding instructions for use (ifu) regarding functional checks and cutting edges.Conclusion and measures / preventive measures: based upon the investigation results, no failure could be detected regarding the complained failure pattern; functions as intended.Based upon the investigations results a capa is not necessary.

Event Description

Clarification: the procedure was completed successfully.A replacement device was not required and there was no surgical delay.

• Brand Name: SPARE CUTTER F/GB302R/GB303R/GB307R
• Type of Device: HIGHSPEED POWER SYSTEMS
• 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: 15545660
• MDR Text Key: 301590282
• Report Number: 9610612-2022-00287
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

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
• Device Operator: Health Professional
• Device Model Number: TE562
• Device Catalogue Number: TE562
• Device Lot Number: 52758143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2022
• 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