MAUDE Adverse Event Report: AESCULAP AG CERAMIC ELECTRODE TIP L-HK F/GK372R; LAPAROSCOPIC SURGERY

Model Number GK383R

Device Problem Component Missing (2306)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, (b)(4) materials, process methods or other technological characteristics are registered within the u.S.K970541.Investigation: vigilance investigator carried out the pictorial documentation microscopically.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.Beside the fracture pattern as well as at the proximal end, corrections and residues can be found.An abrasion on the circumference of the material of the tip could be recognized.Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale: due to the age and the signs of wear and tear, the error was most likely caused by a combination of wear and tear and a final overload situation.We assume the wear and tear was the cause of the abrasion since the device was manufactured in 2015.No capa necessary.

Event Description

It was reported the tip broke off intraoperatively.The reporter indicated that the tip of the instrument broke off during surgery.It is unknown if the broken off part fell in the abdominal cavity.No additional x-ray was performed.It is unknown if the broken off part was left in situ.Per the reporter, it can be possible that the broken part fell on the floor of the operating room.It can also be possible that the broken part fell in the body cavity.It is unknown.Per the reporter, the responsible person found it was such a little fragment that it was almost impossible to find it back.Another instrument was used to continue the surgery.There was no delay in surgery.The current status of the patient is healthy.A request for additional information has been made, however, not yet received.

• Brand Name: CERAMIC ELECTRODE TIP L-HK F/GK372R
• Type of Device: LAPAROSCOPIC SURGERY
• 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: kerstin rothweiler ; am aesculap-platz; tuttlingen, baden-wurttemberg 78532 ; GM 78532
• MDR Report Key: 8764617
• MDR Text Key: 150149544
• Report Number: 9610612-2019-00416
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: SEE H10
• 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: 07/05/2019

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
• Device Operator: Health Professional
• Device Model Number: GK383R
• Device Catalogue Number: GK383R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Is the Reporter a Health Professional?: Yes
• Device Age: 46 MO
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other