MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE FORCEPS INSERT

Model Number 33310C

Device Problem Crack (1135)

Patient Problems Unspecified Mental, Emotional or Behavioural Problem (4430); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/19/2022

Event Type  Injury  

Event Description

"it was reported that during a vaginal extraction of the uterus with adnexa, where a morcellation was indicated due to the size of the uterus, it was noticed that the forceps was broken and one of the jaws was missing.The missing jaw could not be detected by using x-ray.Therefore, the abdomen had to be opened with a pfannenstiel incision.The jaw was found on the left side of the upper abdomen behind the spleen.The surgery time was prolonged, and the surgery was extended from a laparascopy to a 10cm laparotomy." internal karl storz reference number: (b)(4).

• Brand Name: CLICKLINE FORCEPS INSERT
• Type of Device: FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 15925966
• MDR Text Key: 304918615
• Report Number: 2020550-2022-00318
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 4048551134092
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2022,12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33310C
• Device Catalogue Number: 33310C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other